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ISS AG is actively participating as exhibitor and a dedicated team will be glad to welcome you on the booth #17, sector A.

Hansjörg Riedwyl (CEO), Yannick Soom (Senior Software Engineer) and Marie Gaumet (Business Development & Project Management, Western Switzerland) are looking forward to learn more about your projects and see how ISS AG could support you in facing the new challenges of medical device registrations as well as their maintenance on the market, including how to implement PMCF (Post Market Clinical Follow-up) studies.

The Swiss Medtech Expo is the Swiss meeting point for the medtech supplier industry with the most important exhibitors, novelties, application examples, exhibits, expert lectures and much more.

Thanks to a protection concept implemented by Swiss Medtech according to the protective measures prescribed by the Federal Office of Public Health FOPH, this event takes place in Bern on 21 September 2020.

You are welcome to contact us in advance to arrange a meeting:

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 Booth promo V3

Hansjörg Riedwyl, CEO of ISS AG, will lead the breakout session #4 entitled “Artificial Intelligence & Medtech: between leaps in innovation and approval hurdles”.

The goal of this session is to provide insights into the current status of Artificial Intelligence in the medtech industry and to provide concrete ideas how to tackle the approval hurdles in order to encourage companies to include AI-considerations in their product strategies.

Daniel Diezi and Gabriel Krummenacher (Zühlke Group AG), as well as Kay-Uwe Clemens (Carl Zeiss Meditec) and Corne de Jong (Healios AG) will also actively participate to the present session.

More information and registration here.

The new edition of the ISO 14155 reinforces the principles of good clinical practices (GCP) in clinical investigations with medical devices. While the principles were defined earlier and belong to the state of the art in research involving human beings, the new ISO 14155 specifies further elements and embed them into requirements according to MDR. A special focus is on risk management during the clinical investigation process, where a tight relationship to ISO 14971 is described.

Helpful is the clarification of applicability of the requirements of the new ISO 14155 to the different clinical development stages in line with recent MDCG guidelines and MDR.

The third edition cancels and replaces the second edition (ISO 14155:2011), which has been technically revised. The major changes to the previous edition are as follows:

- inclusion of a summary section of GCP principles (see Clause 4);

- reference to registration of the clinical investigation in a publicly accessible database (see 5.4);

- inclusion of clinical quality management (see 9.1);

- inclusion of risk-based monitoring (see 6.7);

- inclusion of statistical considerations in Annex A;

- inclusion of guidance for ethics committees in Annex G;

- reinforcement of risk management throughout the process of a clinical investigation (planning to consideration of results) including Annex H;

- clarification of applicability of the requirements of this document to the different clinical development stages (see Annex I);

- inclusion of guidance on clinical investigation audits (see Annex J).

Adhering to  the new edition of ISO14155 is a prerequisite for acceptance of clinical data in safety and performance assessments of medical devices in EU and foreign regions.

Instead of the MDR & IVDR Conference, which was postponed to 25 March 2021 due to the coronavirus pandemic, an online event with information on the MDR, the Mutual Recognition Agreement between Switzerland and the European Union and the new national Medical Devices Ordinance (MepV) will take place in the morning of 15 September 2020. ISS AG will be represented by Bernhard Bichsel who is going to explain what you need to do about the MRA between Switzerland and the EU.

Further informations about the programm and the registration form can be found here:

https://www.swiss-medtech.ch/en/events/event/mdr-ivdr-online-conference-15-september-2020

In order to better protect patients, the Federal Council wishes to improve the quality and safety of medical devices. At its meeting on July 1, 2020, it accepted the revision of the ordinance on medical devices as well as the new ordinance on clinical trials of medical devices.

ISS AG CRO supports manufacturers of IVD and medical devices in the compliant execution of clinical trials.

Link to the press release of the Federal Council: https://www.bag.admin.ch/bag/de/home/das-bag/aktuell/medienmitteilungen.msg-id-79637.html