FDA
2021-03-26
FDA Approval Process for Medical Devices: Step-by-Step Guide
This article focuses on the FDA approval process for medical devices, providing a step-by-step guide to accessing the US market.
Product compliance
2021-03-09
Market Surveillance Regulation (EU) 2019/1020: Does It Apply to You?
This article provides information on the new EU Market Surveillance Regulation 2019/1020, coming into force on July 16th, 2021.
CE marking
2021-03-03
Responsibilities and Mandate of an EU Authorised Representative
This article helps you understand what an EU authorised representative is and what their general responsibilities are.
CE marking
2021-03-02
Medical Device Technical File for MDR Compliance
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.