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.
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.
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.
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.
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.
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.
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.
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.