©: Certification has been initiated©: Certification has been initiated

07-28-2022 Despite all oppressive circumstances that are currently making life hard for medical device manufacturers - and which could potentially threaten the existence of some of these companies - we have succeeded: FUSE-AI and their products will be certified by the Notified Body BSI Group!

"We are pleased about our new client FUSE-AI GmbH from Hamburg, Germany. We have been mandated to certify the Quality Management System (QMS) according to ISO 13485 and Medical Device Single Audit Program (MDSAP). The required certification is the basis for CE marking compliance and FDA 510(k) submission to make "©" available to the US and European market." Frederic Becker, BSI Group.

The MDSAP enables medical device and in vitro diagnostic manufacturers to cover with normative and regulatory requirements of up to five target markets by completing only one audit process.© will be approved for: Australia, Canada and the United States of America.

An MDSAP audit from BSI can also be combined with ISO 13485 certification. FUSE-AI has been a registered medical device manufacturer with the BfArM (German Federal Institute for Drugs and Medical Devices) since 2021.

The current situation in the regulation of medical devices is very challenging, as there are significantly less Notified Bodies and even less resources than previously available within the EU In-vitro Diagnostic Device Regulation (IVDR) and the EU Medical Device Regulation (MDR) compared to the previous directives. These gaps are confronted with even more products to be certified in a shorter period of time, as well as to more complex audits and examinations.

Associations such as the German Medical Technology Association (BVMed) and the Association of the Diagnostics Industry (VDGH) claimed "immediate interventions to ensure patient care according to MDR & IVDR" in a common paper already in May 2022. They currently expect negative consequences for the human health care in Germany and Europe.

Also at the 'Johner Institute Day' (we reported in July), the hope for an early relaxation of the situation was very restrained among all guests and a general loss of innovation is feared.

Therefore, we are excited to announce that© will be soon available in many countries around the world to assist physicians in prostate MRI diagnosis.

No Comments Yet.

Leave a comment