There is now the choice of 13 designated notified bodies for the IVD Regulation as articulated here.
Ben KempSeptember 11, 2024
In preparation for incoming AI legislation, BSI has proactively developed an Algorithm Auditing and Dataset Testing service to help organizations prepare for success. An Algorithm Auditing & Dataset Testing confirmation letter from BSI demonstrates to customers, regulators, and other stakeholders that your algorithm performance claims have been verified by an impartial and independent third party. Establish trust and credibility in…
Ben KempSeptember 11, 2024
DoP curbs unethical practices with new guidelines for medical device promotions, mandating transparency and strict adherence to regulatory approval. You can read the article here.
Ben KempSeptember 11, 2024
RAPS are looking for volunteers to join their Regulatory Compliance Certification Program (RCC) IVD Steering Committee. If you are interested, please fill out and submit the form below: https://connect.raps.org/volunteeropportunities/opportunities-list-public/volunteer-opportunity-details?VolunteerOpportunityKey=29c88aa3-0173-4c28-8e39-0190b796f74e&returnurl=https%3A%2F%2Fconnect.raps.org%2Fvolunteeropportunities%2Fopportunities-list-public Please click here for more information and to sign up: Regulatory Compliance Certification (RCC) Item Bank Maintenance Join the RCC-MDR Committee Join the RCC-IVDR Committee
Ben KempSeptember 4, 2024
The EFLM Task Force "Direct-to-Consumer Testing" has published the following scientific paper: Direct-to-consumer testing as consumer initiated testing: compromises to the testing process and opportunities for quality improvement. You can access it here.
Ben KempSeptember 4, 2024
The Swiss Federal Council, has request that Swiss law be updated to reflect the EU IVDR Transition timelines, to avoid loss of devices from the Swiss market. You can read more here.
Ben KempAugust 21, 2024