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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 and in Vitro Diagnostic Regulations. The event covers a variety of topics related to the regulations, speakers come from regulatory bodies and the industry. (source).

Hansjörg Riedwyl will talk about challenges for SMEs under MDR / IVDR. See here for the detailed schedule

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.

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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 assistance for the distinction between Lifestyle / Wellness products and medical devices as well as for the preparation of the certification process as medical device.

The guide is accompanied by Checklists, which guides the developer through relevant issues to achieve the development of a secure and compliant medical device.

Link: https://www.e-health-suisse.ch/de/gemeinschaften-umsetzung/ehealth-aktivitaeten/mhealth.html

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 ensure the quality of the collected data and its related maintenance and release processes, a customized content management system was developed.

During the whole development time, ISS AG developed the whole Software and contributed substantial in the areas of Regulatory Affairs, Clinical Services, Quality Management and IT Services.

We congratulate the team of PEDeus on a successful start and look forward to further cooperation.

 https://www.pedeus.ch

 

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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 IIb. ISS AG was involved in different strategic and regulatory aspects of the certification, including the demanding clinical evaluation.