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 […]
In today's highly regulated medical device industry, ensuring quality management and compliance is paramount. As CEOs, COOs, VPs, Presidents, and leaders in Germany and across Europe, understanding and adhering to ISO 9100 standards is not just a regulatory requirement but a strategic imperative. What is ISO 9100? ISO 9100 is an internationally recognized standard for […]