Month: March 2021

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.