On our own account: ISS AG Management buy-out completed
Monday, May 09, 2022
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Sandra Item and Bernhard Bichsel take over the management of ISS AG as co-CEOs and become owners of the company at the same time. Hansjörg Riedwyl will continue to work for the company. The communication for our customers and partners can be found here . Communication en français ici .
Paper on the impending supply deficit
Wednesday, March 23, 2022
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Bernhard Bichsel is co-author of the article (German) published in the journal "Life Science Recht" on the causes of possible supply deficits for medical devices in Switzerland and outlines possible solutions to prevent a supply crisis. Read the article here
ISS AG invited at La Rentrée du DM 2021 à Besançon, France
Wednesday, October 27, 2021
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On October 7th, Annika Lörtscher, our Senior Regulatory Affairs Manager and Teamleader International Market Access, gave an overview on the latest regulatory requirements in Russia, China and Brazil. The conferences of La Rentrée du DM deal with the concrete concerns of medical device manufacturers in the daily exercise of their activity. This event is intended for all those who wish to master...
ISS AG at EPHJ in Geneva
Thursday, September 30, 2021
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ISS AG invited to the EPHJ , the largest international trade show dedicated to high precision, in order to share experience on the development of medical devices at the MedTech roundtable. Contact us as well for strategic or operational support in Compliance, Clinical or Digital MedTech at info@iss-ag.ch . Read more here
First version of European Medical Device Nomenclature (EMDN) made public
Wednesday, June 16, 2021
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At the beginning of May 2021, the first version of the European Medical Device Nomenclature (EMDN) was released. The EMDN plays a vital role in the functioning of the European database on medical devices (EUDAMED) and fulfils the requirement in Article 26 of the MDR. The EMDN is based on the Classificazione Nazionale Dispositivi medici (CND), the Italian nomenclature that was also implemented in...
How to register Medical Devices in China?
Monday, June 14, 2021
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Click on the flyer registration button or just here for this free interactive webinar on Wednesday, 30 June 2021. Following a first successful webinar on the European regulatory requirements, ISS AG and its Asian partner, Qualtech Consulting Corp., joined again their forces to provide you with an insight into the registration of Medical Devices in China. We have designed a compact webinar...
Putting your PMS & PMCF in good hands
Friday, June 04, 2021
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Due to the new EU Medical Device Regulation, manufacturers face increasing requirements regarding Post-Market-Surveillance (PMS). To support you with your PMS needs we have put together a package of services. With our different PMS packages we support you in bringing your PMS System up to date. If you do not want to bother with PMS, we even offer an outsourcing solution with full PMS & PMCF MDR...
New biocompatibility standard paves the way for animal welfare
Tuesday, April 20, 2021
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In January 2021, ISO 10993-23:2021 Biological evaluation of medical devices – Tests for irritation was published. The new standard specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce skin irritation and includes an important test model with regard to animal welfare. Until this new standard was published, ISO...
MDGC issues document on certification of class D in vitro diagnostic medical devices during the transition period
Tuesday, April 13, 2021
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With a little more than a month to go till the date of application of the MDR, the industry is understandably concerned about the readiness of the system. However, another deadline is looming, as the five-year transition period of the IVDR is almost over, with the date of application of the IVDR only one year away. The IVDR introduces the requirement for all products falling into a higher risk...
Swiss Medtech informs about the «Contingency MedDO»
Wednesday, April 07, 2021
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An amendment to the Medical Devices Ordinance (MedDO) has been prepared, which will come into force on 26 May 2021 if the Mutual Recognition Agreement (MRA) between Switzerland and the European Union (EU) has not been updated by that date. This amendment is referred to as the Eventual-MepV (Contingency MedDo), but the explicit content is not publicly available yet. As the clock is relentlessly...
EU proposes modification of current MRA to grant transition validity to certificates issued by Swiss NB
Wednesday, April 07, 2021
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The latest announcement of the European Commission aims to alleviate some of the legal uncertainty surrounding EU market access of Swiss medical devices after the date of application of the MDR in May 2021. To mitigate supply disruptions on the EU market, the EU proposes a limited modification to the current Mutual Recognition Agreement, which would grant certificates issued by a Swiss NB the...
Medical devices on the Indonesian market
Monday, March 08, 2021
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The people of Switzerland voted to pass the free trade agreement with Indonesia. After ratification of the agreement, many products will benefit from lower trade barriers and tariffs. Do you as a manufacturer plan to take advantage of these facilitations and bring your medical devices onto the Indonesian market? Or do you want to expand your existing product range on the Indonesian market and...
New MDCG document outlines harmonised practices and alternative technical solutions until Eudamed is fully functional
Tuesday, March 02, 2021
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In a recently published guidance document , the MDCG aims to provide guidance to the Member States on handling certain MDR provisions applicable as of May 2021, even though Eudamed is not fully functional. To comply with the current Directives, legal manufacturers and authorised representatives of CE-marked medical devices have to register in the EU country where they have their place of...
The IEC has recently published IEC TR 60601-4-5:2021 Medical electrical equipment – Part 4-5: Guidance and interpretation – Safety-related technical security specifications
Thursday, February 11, 2021
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For a while now, cybersecurity incidents in the healthcare sector have been increasing and can no longer be dismissed as random incidents, vandalism by script kiddies or collateral damage of general malware campaigns. The healthcare sector, specifically health delivery organizations and their supply chain, have become a prime target for cybercrime and cyberwar actors. Legislators and regulators...
New INMETRO ordinance eases inspection requirements for medical devices in Brazil
Monday, February 01, 2021
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In order to access the Brazilian market, medical devices have to be notified or registered with ANVISA, depending on their risk class. With RDC No. 423/2020, the Brazilian regulator has recently eliminated the Cadastro pathway for the registration of Class II medical devices and IVDs. This was a considerable reduction of the registration requirements for the manufacturers of these devices. The...
EU Commission allows temporary remote QMS audits under MDR and IVDR
Monday, January 11, 2021
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Today, the EU Commission has published a notice in the OJ that notified bodies might temporarily perform QMS audits remotely in exceptional cases and on a case-by-case basis. Notified bodies can thus deviate from the IVDR and MDR requirement that QMS audits take place on-site. Member States, notified bodies, industry and other stakeholders have insisted that travel and quarantine restrictions...
Global Entrepreneurship Week – November 16th – 22nd
Tuesday, January 05, 2021
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ISS AG, Integrated Scientific Services AG, participated to the 12th Global Entrepreneurship Week. With numerous events organised in 180 countries, the Global Entrepreneurship Week sets out to celebrate entrepreneurship and innovation. The Campus Biotech Innovation Park and Geneus celebrated this event in the heart of Geneva in the form of a Café & Croissant including a virtual tour of the...
ILMAC Lausanne 2020, Medtech Forum operated by ISS AG
Monday, October 05, 2020
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BioAlps and ISS AG, Integrated Scientific Service in collaboration with the Swiss Biotech Association and the Swiss Chemical Society organise a Medtech symposium on Thursday 8 October to provide information to Medtech companies regarding the CE-marking process, specifically within the new EU MDR which has been postponed to May 2021 due to Covid-19. In the form of a round-table, punctuated by...
Guest Lecture by H. Riedwyl on Apps & Medical Device Software
Monday, October 05, 2020
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Guest Lecture by H. Riedwyl on Apps & Medical Device Software, October 21, 2020 at the Center for Digital Health Interventions of ETHZ and Uni SG. Participation is free. More information including the link to the Zoom-Meeting you find here .
Swiss Medtech Day 2020 in Bern
Monday, September 28, 2020
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Thank you very much for your participation to the session on “Artificial Intelligence & Medtech” lead by Hansjörg Riedwyl as well as for visiting our stand and the interesting discussions raised towards the development, registration and maintenance on the market of embedded medical device software and software as a medical device. More info on our services in this field here: ISS AG – Medical SW...
ISS AG at the Swiss Medtech Expo on 21 September in Bern
Tuesday, September 15, 2020
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ISS AG is actively participating as exhibitor and a dedicated team will be glad to welcome you on the booth #17, sector A. Hansjörg Riedwyl (CEO), Yannick Soom (Senior Software Engineer) and Marie Gaumet (Business Development & Project Management, Western Switzerland) are looking forward to learn more about your projects and see how ISS AG could support you in facing the new challenges of...
ISS AG will lead the session “Artificial Intelligence & Medtech” at the Swiss Medtech Day - 21 September 2020 - Bern
Friday, September 11, 2020
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Hansjörg Riedwyl, CEO of ISS AG, will lead the breakout session #4 entitled “Artificial Intelligence & Medtech: between leaps in innovation and approval hurdles”. The goal of this session is to provide insights into the current status of Artificial Intelligence in the medtech industry and to provide concrete ideas how to tackle the approval hurdles in order to encourage companies to include...
ISS AG at the MDR & IVDR Online Conference
Thursday, September 03, 2020
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Instead of the MDR & IVDR Conference, which was postponed to 25 March 2021 due to the coronavirus pandemic, an online event with information on the MDR, the Mutual Recognition Agreement between Switzerland and the European Union and the new national Medical Devices Ordinance (MepV) will take place in the morning of 15 September 2020. ISS AG will be represented by Bernhard Bichsel who is going to...
Third Edition of ISO 14155 has been published
Wednesday, July 29, 2020
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The new edition of the ISO 14155 reinforces the principles of good clinical practices (GCP) in clinical investigations with medical devices. While the principles were defined earlier and belong to the state of the art in research involving human beings, the new ISO 14155 specifies further elements and embed them into requirements according to MDR. A special focus is on risk management during the...
Federal Council to improve safety of medical devices
Wednesday, July 15, 2020
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In order to better protect patients, the Federal Council wishes to improve the quality and safety of medical devices. At its meeting on July 1, 2020, it accepted the revision of the ordinance on medical devices as well as the new ordinance on clinical trials of medical devices. ISS AG CRO supports manufacturers of IVD and medical devices in the compliant execution of clinical trials. Link to the...
Sandra Item and Bernhard Bichsel as guest experts on the MDR postponement
Wednesday, June 24, 2020
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On Thursday, July 2nd 2020 (16:00-17:00), two of ISS AG Senior experts will actively participate in the 1 st SwAPP web-interview regarding the impact of the MDR postponement on Medtech and Pharma. This event takes place on the web in the form of presentations and an interview. Sandra Item, Head of Regulatory Affairs & Knowledge Management, and Bernhard Bichsel, Senior Consultant and Strategic...
Learning more about PMCF ?
Friday, June 05, 2020
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Register here for a free hands-on webinar on Wednesday, 10 June 2020. Thanks to the Clinical Experts of our CRO, we have designed a compact webinar about Post-Market Clinical Follow-up (PMCF) methodology while benefiting from Bernhard Bichsel's insight into the current Regulatory context of clinical data acquisition!
Breaking News – MDR DOA postponed until 26. May 2021
Friday, April 17, 2020
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The COVID-19 pandemic is having a significant impact on the medical device industry, including the preparations for the upcoming implementation of the MDR. On April 17 th the European Parliament voted in favour of the Commission’s proposal to postpone the date of application of the Medical Devices Regulation (MDR) by one year to 26 May 2021. Today the amendment to postpone the DOA was published...
ISS AG participates in the fight against SARS-CoV-2
Wednesday, April 15, 2020
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ISS AG participates in the fight against SARS-CoV-2 by assessing new tests on the market for their regulatory quality and clinical validation. We support our customers in accelerating the market approval of vital medical devices (eg. ventilators) or IVD.
ISS AG Medtech Bootcamp – New talents available for your company
Thursday, April 09, 2020
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“After 4 weeks of the training I can say that the ISS bootcamp is one of the greatest experience in my professional working life.” Serhat Daye This pilot initiative to cope with acute shortage of Medtech experts took successfully place in March and during an intensive month of training, carefully selected boot campers received the essential knowledge to be able to work in Q or RA departments or...
Bernhard Bichsel will join ISS as per May 1st 2020.
Wednesday, March 18, 2020
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Bernhard led Swissmedic’s Medical Device Department during the past 7 years and was a member of various European Working groups. Among others, he was a very active member of the CAMD Executive Group ( https://www.camd-europe.eu ), where he was heavily involved in MDR/IVDR implementation activities. Originally, he started-off as an Electrical Engineer, focused on production, verification and...
ISS MedTech Bootcamp - Information Week 3
Monday, March 16, 2020
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Due to the present context (COVID-19), we slightly adapted the program of our Medtech Bootcamp. We decided that the lectures will be held remotely (webinar) from today on. Only the crews who remain welded and join forces can keep the boat floating and maintain the right heading…
ISS MedTech Bootcamp: Impressions of yesterday's topic: Usability, IEC 62366.
Wednesday, March 11, 2020
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It was very interesting to have Andreas Baier, Director & Principal of Ergonomics Factory GmbH as our guest speaker. More about our evening program: https://www.iss-ag.ch/de/bootcamp-event-program If you would like to participate, please send us an e-mail: bootcamp@iss-ag.ch
Week 2 of the ISS MedTech Bootcamp
Wednesday, March 11, 2020
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A big thank you to Thomas Bohnen, CEO Qualitätsplan Lübeck, DE for the interesting speech yesterday evening about how 60601-1 tests are set up in practice. More about our evening program: https://www.iss-ag.ch/bootcamp-event-program If you would like to participate, please send us an e-mail: bootcamp@iss-ag.ch
Hansjörg Riedwyl as guest lecturer at the ETH Zurich
Friday, March 06, 2020
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On Thursday, 19 March 2020 (10:15 am – 12:00 am), Hansjörg Riedwyl, CEO of Integrated Scientific Services in Biel and expert in business development, will give a guest lecture at the ETH Zurich (Maschinenlaboratorium, Sonneggstrasse 3, Room ML H 37.1). The lecture is about Apps and Medical Device Software. Digital health interventions offer a lot of new opportunities for all involved, not only...
Bootcamp Day 2: Visit at Bern University of Applied Sciences
Thursday, March 05, 2020
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Thank you Bern University of Applied Sciences for letting us have a sneak peek into you interesting living lab of medical informatics. And a big thank you to Thomas Bürkle for the interesting presentation.
Searching for new Talents in Q/RA: we are selecting and training new talents for Q/RA for the Swiss MedTech Industry.
Tuesday, January 21, 2020
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We are searching for new talents in Q/RA for the Swiss MedTech Industry. If you are selected for our bootcamp, which will take place March 2 nd to March 27 th in Biel, you can benefit from our high density (1 month) training program. This includes MedTech topics (RA, Q), industry insights, soft skill (e.g. Project Management) as well as an exam at the end of the bootcamp. The bootcamp is free...
Join the first MedTech bootcamp, taking place March 2nd to March 27th 2020 in Biel
Tuesday, January 21, 2020
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If you are FH/UNI graduate, junior professional or a newcomer to Medtech of any age, highly motivated to work in a dynamic and international environment and if you have an interest in medicine and technology, join the first MedTech bootcamp, taking place March 2nd to March 27th 2020 in Biel. The bootcamp will give you the necessary hard- and soft-skills for a career within MedTech Industry. The...
Hansjörg Riedwyl and Matthias Steck as speakers at the Regulatory Journey of Health Tech Cluster Switzerland
Monday, December 23, 2019
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The Regulatory Journey will take place in Schlieren on Thursday, 16 January 2020 at 14.00. The event will deal with relevant regulatory aspects. After a keynote on the topic "Final sprint MDR - Suggestions for the last mile", further topics will be discussed in depth in nine workshops and the questions of the participants will be answered. ( source ). One of the workshops will be conducted by...
Hansjörg Riedwyl as guest lecturer at the University of St. Gallen
Tuesday, October 08, 2019
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On Wednesday, 16 October 2019 (16.15 - 18.00) Hansjörg Riedwyl, CEO of ISS AG in Biel, will give a guest lecture at the University of St. Gallen , Dufourstrasse 50 (room 09-011). The topic will be "Apps and other Software as Medical Device". Digital health interventions offer many new opportunities to all involved, but there are also hurdles to consider. This means that digital health...
ISS-AG is co-author of the strategy paper " The future of previous OEM PLM constellations in the Medical Technology Industry", published by MedicalMountains GmbH.
Monday, September 30, 2019
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With the application of the EU-MDR, the OEM/PLM relationships that have been frequently practiced so far will be a thing of the past. So far, the OEM ("Original Equipment Manufacturer") has been able to concentrate on the development and manufacture of its products and sell them without a name to a PLM ("Private Label Manufacturer") who was the sales expert. All he had to do was apply his own...
Hansjörg Riedwyl Speaker at the MDR Support Panel - Third State Regulation
Tuesday, August 27, 2019
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On October 23rd, 2019 the MDR Support Panel will take place in the new sitem-insel building, Freiburgstrasse 3, 3010 Bern. The background to this event is the adoption of the new EU legislation in the field of medical devices (MDR), for which regulatory issues in particular have not yet been clarified. The topic will be the regulation of third countries. As adoption of the framework agreement is...
Hansjörg Riedwyl speaker at Medtech 2020 and Beyond: Tips for Survival in Europe’s New Medtech Environment Wednesday, October 30, Hotel Bellevue Palace, Bern
Thursday, August 08, 2019
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Hansjörg Riedwyl, CEO of ISS AG, Integrated Scientific Services, will have the opportunity to speak at the Event “Medtech 2020 and Beyond: Tips for Survival in Europe’s New Medtech Environment”, which will take place Wednesday, October 30 at the Hotel Bellevue Palace in Bern. The event addresses management and business development and focusses on strategic impact of the new EU Medical Devices...
Successful OEM/PLM Symposium in Tuttlingen
Wednesday, July 10, 2019
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Many business models in the Tuttlingen region are based on OEM/PLM constellations. Here the MDR (EU 2017/745) is a special challenge. At a symposium, the various aspects and possibilities were discussed and supplemented with concrete examples from practice. In a keynote speech, Hansjörg Riedwyl presented five different strategic options and made assessments on feasibility and the risks involved.
Successful start of PEDeDose
Monday, July 01, 2019
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The „Software as Medical Device“ (short: SaMD) product PEDeDose of the company PEDeus launched successfully in March 2019. PEDeDose supports healthcare professionals in prescribing pediatric medication and provides patient-specific information. The software can be accessed by any mobile- and desktop browser, or be transparently integrated into an existing system by using its web service. To...
Manual and Checklists for the development of secure health apps
Tuesday, June 05, 2018
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ISS AG developed on behalf of eHealth Suisse a manual and checklists for the development of secure health apps. Software engineers have to ask themselves very early in the process of developing a health app, if their product falls into the category of a medical device and which regulation they have to adhere with. The manual supports the software engineers in this process. It provides practical...
ISS Spin-off received IIb certification
Tuesday, May 01, 2018
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ISS spin-off, Optimo Medical AG , has received the certification for their class IIb product Optimeyes. This clears the way to use Optimeyes for very challenging operation planning in ophthalmology. To the best of our knowledge, Optimeyes is one of the first stand-alone software medical devices in Switzerland to overcome the considerable obstacle of the certification as a medical device in class...
Event: New MedTech EU MDR/ IVDR Regulations - Consequences and Solutions (January 30th 2018)
Monday, December 18, 2017
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The new Medtech EU MDR/IVD regulations published at the end of May pose a major strategic and operative challenge to the entire industry, and they will have a major impact on the business performance of many companies and SMEs. All companies are strongly challenged. The first stakeholders have prepared GAP analyses to realize the tight implementation requirements by 2020 (MDR) and 2023 (IVDR)....
ISS-Talk at the Tuttlinger Innovationsforum on October 19th
Wednesday, August 02, 2017
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Digital Regulatories is a hot topic. The title of Hanjoerg's (CEO of ISS AG) speech at the Tuttlinger Innovationsforum will be “Digital RA, a contribution to a shorter time to market”. The fact, that we were invited for this talk shows, that there is a lot of interest for this topic. However: ISS is investing for the simplification of Regulatory Submission processes by the means of IT for a long...
3D Printing, impact of MDR
Sunday, June 25, 2017
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ISS CEO Hansjörg Riedwyl is a speaker at the symposium “3D Printing for Life Sciences” in Muttenz on July 4th 2017. 3D Printing is one of the mega trends in Life Science. The Regulatory Situation is not clear in many aspects, therefor the potential impact of the new European regulation is of great interest. Hansjörg Riedwyl will point out, what is already clear, what the MDR will bring and where...
Formation – Évaluation clinique selon MEDDEV 2.7/1, Révision 4
Thursday, March 02, 2017
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ARIAQ et ISS AG proposent une formation d’une demi-journée pour les fabricants de dispositifs médicaux dont l’objectif est d’illustrer les exigences des évaluations cliniques selon « MEDDEV 2.7/1, Révision 4 » par des exemples concrets de mise en application en Suisse. Actuellement, la création d’une évaluation clinique est un défi pour l’industrie. Cette formation offre un programme ad hoc vous...
Further clinical evaluation of ISS AG meets the requirements
Thursday, January 26, 2017
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The process established by ISS AG for the preparation of clinical evaluations was again recognized by a positive assessment from a well-known Notified Body. "The clinical evaluation was established after MEDDEV 2.7.1 rev.4 and fulfills the requirements of MEDDEV 2.7.1 rev.4" We are very pleased that we have been able to support our customers in the certification of a Class IIb implant.
ISS AG is now a member of the BVMA e.V.
Monday, December 05, 2016
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ISS AG has been accepted as a member of the BVMA e.V. The Federal Association of Contract Research Organisations (BVMA) e.V. was founded in July 1991 to represent CROs (Contract Research Organisations) which are based in Germany or German speaking countries.To make sure that each member satisfies the high quality demands, all members undergo re-auditing every three years. We are very pleased...
ISS AG has been successfully audited as clinical Contract Research Organisation (CRO)
Friday, November 25, 2016
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The audit served to assess ISS’ adequacy and quality level in order to assure that the systems, procedures, practices and documentation at the CRO comply with Good Clinical Practice (ICH GCP), relevant national and international GCP requirements, CRO policies and procedures, and generally accepted good practices.
Regulatory Affairs Software – No more missed deadlines
Tuesday, November 01, 2016
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Read our article in the medical journal DeviceMed With our Regulatory Affairs Software REGULA™ daily RA activities can be greatly simplified. This increases efficiency and shortens the time to market, which finally results in more turnover. This article was one of the most read DeviceMed articles in November 2016. Read our article in the medical journal DeviceMed to get more information about...
Successful application of MEDDEV 2.7/1 Rev. 4 for clinical evaluations
Monday, October 24, 2016
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For several weeks now new, substantially stricter rules have been in place for clinical evaluations. All notified bodies known to us now require the application of Rev. 4 of the corresponding MEDDEV 2.7/1. The absence of an updated clinical evaluation according to Rev. 4 during an audit is considered to be a major non-conformity. We have adapted our processes and practice accordingly and in the...
Successful maintenance audit for ISO 13485
Thursday, May 26, 2016
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The ISO 13485 certification of the ISS AG was successfully maintained. The auditor issued a thoroughly good report and recommends maintaining the ISO 13485 certification without corrective actions requirements. This allows ISS to consolidate its position as a credible service provider in the fields of software development, regulatory affairs, clinical evaluations, clinical studies (CRO) and...
Meet the Expert Implants Interlaken
Thursday, June 25, 2015
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The abstract of SpineWelding and ISS AG is published. Our company, ISS AG, participated in the congress and was presenting together with SpineWelding AG an abstract on Clinical investigations with implants: View of the development company and of the CRO. Link eCM Journal
Surveillance Audit by Notified Body DQS
Wednesday, June 24, 2015
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The QMS of ISS was recertified successfully by our Notified Body DQS. The main Focus of the audit was on the process of software development and the Clinical Research Organisation (CRO). The successful outcome is confirming our undertakings of the last months in further developing the CRO business. The audit was closed with no deviations noted.
«i-net Medtech After-Work Regulatory Affairs Circle» with ISS AG
Wednesday, May 20, 2015
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The «i-net Medtech After-Work Regulatory Affairs Circle» is based on requests from participants of last year’s i-net RA Strategy workshop. The intention of the circle is to meet up twice a year to discuss given RA cases and related actualities in an open and constructive manner. The circle is dedicated to medtech related RA, we address the event to people and...
Another success for REGULA™
Friday, February 20, 2015
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A multinational MedTec enterprise is using our RA software: After an intense evaluation phase, another multinational MedTec enterprise has decided to use REGULA™ for all its future submissions. In the already terminated first phase, RA processes of different locations were analysed and standards were searched and defined. The customer is seeking to harmonize and speed up RA processes globally,...
Reinforcement of the ISS Team
Monday, November 24, 2014
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The ISS Team has received reinforcement: Dr. Michel Weber ISS AG decided to strengthen its competence in clinical operation services by building a separate organizational unit lead by Dr. Michel Weber joining the company. His experience as a former COO of international and Swiss Clinical Research and as Head of Clinical Research Operation at Novartis adds a lot of knowledge in all services...
Talk at the ESCRS in Amsterdam with Harald Studer
Wednesday, August 13, 2014
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Harald Studer will have a lecture to a new study at the ESCRS in Amsterdam this year from 05-09 October 2013. The study was done in collaboration with the Ohio State University and compares the biomechanical effects of LASIK Flap and ReLEx Smile Cap Incisions.