Tag: medical devices

Product compliance

2021-04-13

What is Risk Management, and How to Create a Risk Management Plan?

Learn what a medical device risk management plan is and how to create one.

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.

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.

CE marking

2021-02-16

10 Medical Device Symbols You Must Know About

MedTech manufacturers can use the present guidance on medical device symbols to comply with the new, stricter MDR labelling requirements.

CE marking

2021-02-11

EU MDR Labelling Requirements for Medical Devices

This post focuses on the medical device labelling requirements and user manual requirements under the EU MDR 2017/745.

CE marking

2020-03-18

GAP Analysis: EU MDR Compliance

This article provides a general overview of what a gap analysis is in the context of the Medical Device Regulation (MDR) 2017/745.

CE marking

2020-03-17

CE Marking Medical Device Standalone Software – MDR & IVDR Guide

The article provides a general overview of the medical device regulatory process for manufacturers, as well as additional guidance specifically relevant to standalone software.

CE marking

2020-03-08

Medical Device Classification According to the MDR

Manufacturers who want to place their medical devices on the European market must refer to the Medical Device Regulation (MDR) 2017/745 to determine the appropriate risk class of their devices.