This article provides guidance on what documents MedTech manufacturers must include in their medical device technical files. The article also shares insights on how a medical device technical file is assessed for MDR compliance.
MedTech manufacturers can use the present guidance on medical device symbols to comply with the new, stricter MDR labelling requirements.
This post focuses on the medical device labelling requirements and user manual requirements under the EU MDR 2017/745.
This article presents three certification markings for energy-efficient products that manufacturers placing goods on the US market should consider.
Read this guide to learn about the mandatory and voluntary product certification markings for goods placed on the European market.
Some often-required types of product certification are CE marking, FDA, FCC and CB Scheme. You can read about each one of these types of product certification here.