MEDIcept Insights
Engaging a Penetration Testing Team
Introduction Secure design best practices (and various standards and guidance) recommend penetration testing (pentesting) be included in the secure development life cycle and conducted by a team independent of the product developers and testers. Testing should begin...
Breaking Sterilization Barriers – EPA's Bold Move Towards Safer Medical Device Regulation
The U.S. Environmental Protection Agency (EPA) has issued a final rule aimed at limiting emissions of ethylene oxide (EtO), a carcinogenic chemical extensively used in the sterilization of medical devices, with a focus on enhancing medical device regulation. This new...
EU AI ACT and Its Impact on the Medical Device Industry
The provisional agreement on the Artificial Intelligence Act proposed by the European Parliament introduces a unified regulatory framework for AI across the EU, with significant implications for the medical device industry. This paper aims to discuss the potential...
NEW Draft Guidance from FDA – “Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products”
The use of a standardized approach for collecting and reporting race and ethnicity data in submissions including information collected and reported from clinical trials and studies for FDA regulated medical products is essential for all medical product manufacturers. ...
European Commission Proposes to Extend IVDR Transition and Accelerate EUDAMED Adoption
The European Commission is considering extending the transition period for compliance with the In Vitro Diagnostic Medical Devices Regulation (IVDR) due to concerns that manufacturers might not have sufficient time to comply. The IVDR came into force in May 2022, and...
FDA and Clinical Trials Transformation Initiative (CTTI) Collaborate to Improve ClinicalTrials.gov
The prompt and precise registration, as well as the timely dissemination of comprehensive summary results information for relevant clinical trials on ClinicalTrials.gov, play a pivotal role in providing current research insights to various stakeholders within the...