MDR Transition and Technical Files: What You Need to Know
Recent changes to European regulations have sparked a lot of interest and intrigue, and even more questions. So, what specifically do medical device companies need to…
What Should (and Shouldn’t) Go In a Technical File for MDR?
European regulations require manufacturers to create and maintain a technical file as a prerequisite to submitting a Declaration of Conformity, allowing products to be CE marked…
MDR Transition: Why the Change, and What are the Changes?
Changes to European regulations have sparked a lot of talk about new requirements. Around the globe, many wondered what these changes meant, and how they would…