By Adaptive Life Science The European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR) — Regulation (EU) 2017/746 — represents one of the most significant regulatory overhauls in the diagnostics sector in decades. Officially applicable since 26 May 2022, the IVDR replaces the previous Directive 98/79/EC, introducing a more robust, transparent, and risk-based framework for […]

Why Cultural Fit Matters in the Medical Device Industry: Beyond Experience and QualificationsThe medical device industry operates at the intersection of precision, innovation, and compliance. Given the critical nature of its work, designing and manufacturing devices that directly impact patient care, it’s no surprise that experience and qualifications are often the top priorities when hiring. […]

Published by Adaptive Life ScienceSpecialists in Medical Device, IVD, and Biotech Recruitment Why Internal Audits Matter in ISO 13485:2016 Internal audits are a cornerstone of any compliant Quality Management System (QMS) under ISO 13485:2016. For Quality Engineers, Regulatory Affairs professionals, and QMS leaders, these audits are not just about ticking boxes—they’re about ensuring product safety, regulatory readiness, […]

In the medical device industry, compliance with regulations is crucial to ensure the safety and efficacy of products. For companies operating in Germany and across Europe, understanding the relationship between ISO standards and the Medical Device Regulation (MDR) is essential. Understanding MDR Compliance The European Union Medical Device Regulation (EU MDR 2017/745) sets out the […]