Stefan Csomor, CEO Advanced Concepts AG, participant in the workshop "Software as medical device"
"For me it was a very successful workshop with valuable insights."
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 achieving 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 provided the technical documentation.It always amazed me 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."
Bettina Ernst, CEO, PRECLIN Biosysems AG
"Dear ISS Team: Many thanks for your assistance and support during the clinical study as well as your helpful advice regarding the classification of the substance-based medical device (spray)."
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."
Project Manager Start Up in the Zurich area
"ISS AG assisted us in the planning and submission of a clinical trial with an innovative Class III implant in cardiology. We have always been closely involved in creating all the technical and clinical trial documents for a study in children using the product for the first time in humans. ISS AG also assisted us professionally in preparing a comprehensive ISO14791-compliant risk management file. The expertise of ISS AG has led our project to long-term success. As a result of the fact that ISS AG was able to respond to our needs situationally, we went through a steep learning curve."
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."
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.”
Daniel Längle, CEO & Co-Founder 1nfusion
„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.”
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.”
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.”