MedSysCon Medizintechnik GmbHhat einen Beitrag geschrieben.24. März 2025 https://www.medsyscon.com/en/europes-ivd-regulation/ Europe’s IVD Regulation - MedSysCon Medizintechnik GmbHThe IVDR introduces a comprehensive risk-based classification system, categorizing devices into four classes: Class A (lowest risk), Class B, Class C, and Class D (highest risk). Higher-risk devices necessitate notified body involvement, adding pressure on regulatory resources.www.medsyscon.com
MedSysCon Medizintechnik GmbHhat einen Beitrag geschrieben.20. März 2025 https://www.medsyscon.com/en/fdas-view-on-cybersecurity/ FDA's view on cybersecurity - MedSysCon Medizintechnik GmbHThe rapid expansion of wireless, internet-connected, and networked medical devices has heightened cybersecurity concerns for manufacturers and developers. As technology evolves, regulators strive to update and maintain security standards to address emerging challenges.www.medsyscon.com
MedSysCon Medizintechnik GmbHhat einen Beitrag geschrieben.19. März 2025 https://www.medsyscon.com/en/fda-ai-guidance/ New FDA Guidance on AI enabled Device Software Functions - MedSysCon Medizintechnik GmbHThis document provides manufacturers with specific recommendations on how to document AI-powered devices within their marketing submissions. Spanning nearly 70 pages, the guidance is extensive and covers ...www.medsyscon.com
MedSysCon Medizintechnik GmbHhat einen Beitrag geschrieben.17. März 2025 https://www.medsyscon.com/en/eu-import-and-distribution/ Medical Device EU Import and Distribution - MedSysCon Medizintechnik GmbHMDCG 2021-23 serves as an essential guidance document for economic operators navigating Article 16 requirements under MDR and IVDR. It offers clarity on compliance obligations related to relabeling and repackaging, emphasizing the necessity of a quality management system (QMS),www.medsyscon.com
MedSysCon Medizintechnik GmbHhat einen Beitrag geschrieben.16. März 2025 https://www.medsyscon.com/en/blog-ai-act/ The impact of the AI Act on Medical Devices - MedSysCon Medizintechnik GmbHWith the publication of the agreed text of the European Union’s long-awaited Artificial Intelligence Act (AI Act) now available (subject to minor linguistic and numbering tweaks), the message to medtech companies is clear: they will need to begin their journey toward compliance by understanding ...www.medsyscon.com
MedSysCon Medizintechnik GmbHhat einen Beitrag geschrieben.16. März 2025 https://www.medsyscon.com/en/eu-import-and-distribution/ Medical Device EU Import and Distribution - MedSysCon Medizintechnik GmbHMDCG 2021-23 serves as an essential guidance document for economic operators navigating Article 16 requirements under MDR and IVDR. It offers clarity on compliance obligations related to relabeling and repackaging, emphasizing the necessity of a quality management system (QMS),www.medsyscon.com
MedSysCon Medizintechnik GmbHhat einen Beitrag geschrieben.16. März 2025 https://www.medsyscon.com/en/pccp/ FDA - Change Control Plans (PCCPs) - MedSysCon Medizintechnik GmbHIn 2024, the FDA released two important guidance documents on Predetermined Change Control Plans (PCCPs), establishing a regulatory framework that allows medical device manufacturers to implement specific, ...www.medsyscon.com
MedSysCon Medizintechnik GmbHhat einen Beitrag geschrieben.16. März 2025 https://www.medsyscon.com/en/blog-ai-driven-regulations/ Regulatory Guidelines for AI-Driven Medical Devices - MedSysCon Medizintechnik GmbHAI-assisted medical devices have actually existed for some time in the healthcare industry, predominantly in the fields of radiology, cardiology, and general practice/internal medicine.1 Computer-aided detection (CAD) software from ...www.medsyscon.com
MedSysCon Medizintechnik GmbHhat einen Beitrag geschrieben.16. März 2025 https://www.medsyscon.com/en/blog-on-csa/ Decoding FDA's Draft Guidance On CSA - MedSysCon Medizintechnik GmbHThe current state of validation is seen as a hindrance to quicker deployments, with an emphasis on adhering to thorough documentation practices instead of building systems that align effectively with their intended use. A risk-based approach to validation has been around ...www.medsyscon.com
MedSysCon Medizintechnik GmbHhat einen Beitrag geschrieben.8. November 2023 https://www.medsyscon.com/en/blog-sw96/ FDA gives full recognition to AAMI cybersecurity guidance document - MedSysCon Medizintechnik GmbHFDA grants full recognition to AAMI's pioneering guidance document on medical device cybersecurity, ANSI/AAMI SW96:2023, Standard for medical device security - Security risk management for device manufacturers.www.medsyscon.com
