Daniel Steiner, Executive Vice President Operations, Belimed AG - Infection Control
“We thank ISS AG for the excellent support and cooperation in a strategic supplier evaluation project in Europe. Their professionalism and expertise were important factors for the good result achieved.”
Jürg Reist, CEO, Heinz Burkhalter AG
"ISS AG has been supporting us for several years in the maintenance and continuous improvement of our ISO 13485 quality management system and in the annual audits. We are very satisfied with the cooperation. This was also evident in this year's audit, which went off without a hitch. For example, the auditor expressly praised the PMS process proposed by ISS AG as excellent."
Neslihan Umeri-Sali, Product Manager, HCI Solutions AG
"ISS AG has been supporting us for several years with its profound knowledge in PMS activities for our medical devices. Outsourcing saves us a lot of internal work and costs and guarantees us a compliant PMS. We are very satisfied with the solution. Thanks to this close cooperation, HCI Solutions AG can meet the legal requirements without having to build up its own resources. "
Dr. sc. Daniel Keller, Head of Software Development at the Ziemer Group
"I have been working very closely with the company ISS in the field of embedded software for many years. For me, ISS is a reliable partner who ambitiously seeks and finds sustainable solutions. Furthermore, ISS does not hide behind specifications, but thinks along with us and acts proactively. This attitude is crucial to lead complex projects to success"
Dr. Regina Bruggisser, Head of RA, Quality and R&D, ivf.hartmann.info
"ISS supported us in the processing of the clinical evaluations and the change of the product labelling in the context of MDR. We have received very competent and solution-oriented support. We will also be happy to work with ISS in future projects."
Stefan Römer, Head R&D Digital Solutions, Belimed AG
"ISS AG has provided us with a detailed analysis of the complex regulatory situation and concrete inputs adapted to our situation and products, providing us with very competent and comprehensive support in the development of our cyber-security strategy. With a step-by-step approach, we were able to jointly achieve ambitious goals in a new subject area that is still marked with great uncertainty."
Jost Wäfler, former Head QM, forteq AG
"The ISS team has supported us very efficiently and competently in the context of establishing and improving outsourced sterile processes. The additional and very short-term support during an audit was very important and helpful for us."
"Thank you for your work on the regulatory statements and our follow up discussion on the intended purpose narrative. Both, statements and discussion have successfully addressed the xMotion project needs. Thank you again for your help. It's been a pleasure working with you all and hope to see you soon!"
"ISS AG supported us in the introduction of a COVID-19 test in Switzerland with high competence and responsiveness."
Business Transformation lead, major health insurance company
"I was very impressed by the quality of the support in the short period of time we had to evaluate our e-health market entry opportunities. The team is highly knowledgeable, available, proactive and solution oriented."
Dr. Fabien Rebeaud, PhD, Chief Science Officer, Abionic SA
"ISS AG accompanied us in our first large international (four countries), multi-centric (14 sites) study of our medical device “abioSCOPE” and we were very satisfied with the quality of the support they provided to us all along the project. The team is very responsive, competent and reliable. Through this project, ISS AG has been instrumental to help us achieving one of our important development milestone, the CE marking of our rapid sepsis diagnostic test on our point-of-care IVD platform."
Prof. Dr. Tobias Kowatsch, Assistant Professor for Digital Health at the University of St. Gallen and Scientific Director of the Center for Digital Health Interventions at ETH Zurich and University of St.Gallen, www.c4dhi.org
"As part of the Digital Health event, Mr. Riedwyl was able to inspire our students in his guest lecture "Apps and Other Software as Medical Device" and give a great overview on the regulatory challenging topic."
Quality Management & Regulatory Affairs, Eppendorf AG
"ISS AG has competently supported us with specific and challenging questions within the scope of various regulatory projects for Europe and other countries."
Karl Larsson, CEO, Aligned AG
"It was a true privilege and to present Hansjörg Riedwyl as main speaker at the 2019 “Sharpen your Skills” MedTech Aligned Seminar. Mr. Riedwyls insightful talk ”The way to MDR: real world experience” covered a set of highly relevant aspects of how medical device manufacturers can analyse and address MDR related uncertainties during their adaptation process."
Daniel Maibach, Head of Counselling and Therapy, Bernese Health
"We thank you for the really exceptionally agile and speedy processing of our request to differentiate our e-health app."
Mario Stark, CEO, Vivior AG
"We are a Digital Heath Start-Up in the field of ophthalmology and general vision correction. ISS supported us very well in the evaluation of the RA strategy as well as in the planning and preparation of the approval documents for the medical device with knowledge, documents and practical work. We were able to complete the notification on time."
Stefan Csomor, CEO, Advanced Concepts AG, attendee Workshop "Software as Medical Device"
"For me it was a very successful workshop with valuable insights."
Daniel Schmid, Dipl. Computer Scientist, Dipl. Business Analyst NDS HF
"In the context of my diploma thesis for the NDS HF BA in connection with the effects of the rev. medical device regulation (MDR) on the systems and applications of a large health service provider, I was able to rely on the competent support of ISS AG. They supported me excellently with valuable basics, a lot of expert knowledge and constructive feedback. Thank you very much for the great cooperation."
Bettina Ernst, CEO, PRECLIN Biosystems AG
"Dear ISS Team: For your assistance and support during the clinical study as well as for your very helpful advice regarding the classification of the material medical device (spray), we would like to thank you very much once again!"
Project Manager Start Up in the Zurich area
"ISS AG supported us in the planning and submission of a clinical study with an innovative Class III implant in cardiology. We were always closely involved in the preparation of all technical and clinical study documents for a children's study in which the product was used in humans for the first time. ISS AG also supported us in a professional manner in the preparation of a comprehensive ISO14791-compliant risk management file. ISS AG's expertise has led our project to lasting success. Because ISS AG was able to respond to our needs according to the situation, we went through a steep learning curve."
Stefan Leinweber, Head of Quality Management, Zimmer MedizinSysteme GmbH
"ISS AG has been our partner for clinical assessments and Q-support for many years. The collaboration has greatly improved the quality of clinical evaluations, each evaluation has been accepted by our notified body. Especially the execution of exploratory pre-assessments before the actual evaluation has greatly simplified the definition of product requirements at the beginning of the R&D process. Even at tasks scheduled at very short notice, ISS AG proved to be a flexible and reliable partner with high quality standards. ISS AG also conducted internal audits at our company. The external view helped us to continuously improve our QMS, the audits were well prepared, took place in a pleasant atmosphere and, thanks to the great experience of the auditors, were very educational for our employees."
Roger Dubach, former Director QM&RA, Ardo medical AG
"I would like to take this opportunity to thank you for your support in the timely and pragmatic preparation of the clinical evaluation after Revision 4. This is a real pleasure to work with you."
Arno Stienen, former Director at Motek Medical BV
"ISS has been a great source of advice with some of the more challenging aspects of the regulatory requirements. With their help, we have worked towards MDR compliance and they showed time and time again to be able to understand our business and how to apply the rules most efficiently. We strongly recommend their services!"
Dr. med./ med. dent. Arno König, Ceramic Solutions AG
"ISS AG has prepared the clinical evaluation for our zirconia dental implant. The execution has fallen in the transition period between Rev. 3 and Rev. 4 of the MEDDEV 2.7 / 1, which made the work very demanding. With great expertise, ISS AG has contributed to our CE certification and proved to be a very fair business partner."
Patrick und Sandra Kugelmeier, Founders of Kugelmeiers AG
"We conducted a workshop on the subject of Clinical & Regulatory Strategy at ISS AG. We were very impressed with the careful preparation and felt very well accompanied by Mr. Weber. Leaving the workshop, we saw things much more clearly. Highly recommended."
Beat Spalinger, Delegate of the Board of Directors and CEO, Belimed AG
"In a highly complex project, we implemented a parallel transfer of production sites and concentration on a legal manufacturer. This required the international re-registration of our entire product portfolio in around 70 countries, for which ISS was responsible. At the same time, an early recertification of our QM system took place at 4 international sites. Deadline and budget could be kept. This joint effort led to a sustainable streamlining of approvals and a reduction in audit effort. At the same time, we have outsourced the operational RA activities to ISS, as our resource requirements fluctuate greatly in this area. ISS can react flexibly to this. This has further relieved the burden on our organization. The cooperation is very good and professional at all times."
Daniel Längle, CEO & Co-Founder, 1nfusion AG
„We had a workshop about the regular strategy for our MedTech startup and were very happy with how Mr. Riedwyl handled the session. It was a very open, highly interesting and informative dialogue, giving us precious insights and helping us to set up our regulatory strategy to reach certification. The know-how of ISS with the open attitude of the team, listening to us as customers, was perfect for getting the information we need on our next steps. Thanks to Hansjörg Riedwyl and his team.”
Hans Rudolf Sägesser, CEO, Schaerer Medical AG
„The ISS company has supported us target-oriented and competently in international regulatory questions.”
Ralf Schumacher, CEO, Co-Founder MIMEDIS AG
„For any Medtech company, and especially for startups, regulatory affairs are topics which are absolutely essential but not easy to deal with. All these directives, paragraphs and standards reveal details which are easily underestimated and could potentially have a huge impact on strategic steps towards selling medical devices on different markets. Our company took a good opportunity by attending this 'regulatory affairs strategy workshop'. We could benefit from thematic inputs of regulatory experts but also from exchanging experiences with other companies along with this workshop. Many thanks to i-net and to ISS.”
Michael Kirsch, Manager Process & Validation Engineering der Zimmer GmbH
„With profound knowledge, pragmatic solutions and a consistently high level of quality, the ISS AG provided a great and valuable service for us in our daily operation, for the qualification of GMP relevant manufacturing. Due to technical expertise and competence in the fields of laser processing and statistics, we were able to gain a better understanding of the processes in the interest of our customers.”
Judith Bernardo, Regulatory Affairs Manager with Smith & Nephew
„REGULA™ was optimally adapted to our processes and requirements in close collaboration with ISS.”
Prof. Dr. med. Fritz Dannheim, Birte Roberg
„For a project about the valence of the ocular pulse curve we received support from ISS with the statistical processing of our material to our utmost satisfaction. We obtained comprehensive consulting, analyses and various leads for the further processing of the data in excel, which we appreciated very much.”
Susanne Dröscher, PhD, Co-CEO, caru AG Zürich
"As a young company, we wanted to clarify at an early stage whether we would be classified as a medical device with our planned product functions. The competent advice provided by ISS not only answered this question, but also gave us the necessary understanding to be able to carry out such an initial assessment independently in the future. Very recommendable!"
Dr. phil. nat. Priska Vonbach, MSc ETH Pharm. Wiss., CEO, PEDeus AG
"ISS AG made a significant contribution to the fact that we were able to achieve CE approval for our "PEDeDose" software. In close cooperation with us, ISS AG developed our "PEDeDose" software according to our specifications as a medical device and also supplied the technical documentation. It amazed me again and again how the employees of ISS AG dealt with the high complexity and implemented our requirements regarding data management, calculator, website and web service with great competence. A big compliment to the developers, the project management and the Q-Team!"
Mathieu Horras, CEO, aspivix
"Thank you very much for the excellent workshop this morning. It is was extremely instructive and pointed out on some areas requiring attention.Thank you also for the inputs and written comments already delivered."
Michael Treas, Chief Compliance Officer, Hollywog, LLC
"ISS AG provided superb EU Clinical Evaluation services to support the CE Mark of our Class IIa transcutaneous electrical nerve stimulation device. We highly recommend the services provided by ISS AG."
Florian Kübler, Senior Clinical Research Associate, AVA AG
"As part of a postgraduate diploma, a Certificate of Advanced Studies (CAS) in the field of clinical trial management, I was able to complete a one-week internship at ISS AG in Biel in spring 2018. In addition to a holistic view of the daily services in the world of medical devices, I have gained a deeper insight into the clinical services department. I have been impressed by how systematically work is performed here without missing the human component. The insights into various SOPs, monitoring plans, and the internal eCRF were very exciting for me. I really appreciate the good atmosphere and the nice way of collaboration in the company. I am convinced that all these are responsible for the excellent work that is carried out here."
Christof Böhler, PhD, Board Member, Pantec Biosolutions AG
„After several rejections of our clinical investigation we contacted ISS AG. The collaboration with ISS AG resulted in the approval of the study.”
CQO, Ophthalmology company
„Owing to the efficient and professional job by ISS, we received the market release in the USA in time and could also use the compiled documents for the CE marking.”
CEO, Development Company Dermatological Laser
„The evaluation of the clinical data from our technology field performed by ISS was essential for the CE marking of our product and for the approval of the execution of our own clinical trials. The demonstration of options for the obtaining of the market access was directive for the arrangement of the project plan.”
Vice President, Ophthalmology Company
„The statistical analysis of our manufacturing process performed by ISS helped us to focus corrective actions, and to provide a strong rationale for the effects of process changes for submission to FDA.”
Development Engineer, Ophthalmology Company
„The competent consulting by ISS through the planning, execution and analysis of a complex study comparing five measurement systems helped us to optimise the efforts of the data collection as well as to attain the relevant information immediately. The method of the data collection enabled us to statistically analyse over 7000 values according to numerous criteria. Several presentations and publications could be generated in a very short time.”
Head of Delivery Control, Ophthalmology Company
„Thanks to the support and software by ISS I am able to save the manual and time-consuming filtering of data and execute the compilation of raw data within seconds now.”
Regulatory Affairs Consultant
„Within a very short time ISS AG compiled numerous submission dossiers in a rule-consistent format with great expertise and therefore helped us to bridge a shortage of resources.”
Head of Development of an SME
„During the shortage of resources in connection with the release of a system in the MedTech sector a software engineer from ISS AG worked for us on-site for a limited time. The competent support and the short training period enabled us to keep the tight schedule.”
Benno Züger, PhD, Project Manager
„ISS AG contributed considerably to the development of a complex medical diagnosis device. They covered the development and implementation of the algorythm for the image analysis, software deployment and additional subprojects.”
René Iten, Head of Quality Management Messer Schweiz AG
„The clinical evaluation prepared for us by ISS was professional and complete in all aspects and also caused a positive feedback from the auditor. The deadlines and the cost frame were kept and the ISS employees were competent and cooperative.”
CTO of a MedTech SME
„Without the intensive support of ISS it would have hardly been possible for us to keep the essential ISO certification in the difficult situation after a partial sale.”
Dr. Benjamin Reinmann, CEO Mathys Ltd Bettlach
„ISS supported us in a due diligence of a medical device software manufacturer. On the one hand, ISS evaluated the maturity and robustness of the systems and the team regarding SW development, but also the QMS and the toolchain. On the other hand, the costs and timelines for the integration were estimated. The extensive know-how in the areas of medical device software development, Q/RA/clinicals and technical documentation under MDR could be impressively brought into the evaluation by ISS and was a very helpful assessment for the potential acquisition."