+41 32 513 6767 | This email address is being protected from spambots. You need JavaScript enabled to view it.

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

 

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 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). There are more questions than answers at this time, especially as the interpretations of the legislation have not yet been established. This is further complicated by the fact that there is a looming shortage in Switzerland for the resources requirements (an estimated 1,400 skilled workers) and in the operative budget of Swiss companies (from up to 400 million Swiss francs per year). (Source: Concep+)
 
The event, which is jointly organized by BaselArea.swiss and Health TechCluster Switzerland, brings together leading experts from the industry and the services sector to discuss the current situation and possible solutions. Using facts, practical examples and stimulating concepts, the presentations and panel discussions will serve as a platform for all those involved to exchange ideas on practical solutions and plans for action.

The event addresses decision-makers in the medical technology sector.

Date: January 30th 2018, 17:00
Location: Halle 7, Gundeldingerfeld, Dornacherstrasse 192, 4053 Basel 

More Information about this event can be found here.

Logo Optimeyes RGB schattiert o 

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.

 

 

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 time, much longer than Digitalization was seen as an important mega trend. The talk will show possibilities and limitations of digital RA.