Robert-Walser-Platz 7
CH-2503 Biel
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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.”

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.”

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.