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Medical Device Quality Management System (QMS)

Medical Device Quality Management System (QMS)

by Allan Murphy Bruun | Apr 14, 2023 | Medical Devices, QMS

A Medical Device Quality Management System (QMS) is a set of policies, processes, and procedures that a manufacturer of medical devices has in place to ensure that their products are safe and effective for their intended use. The QMS includes all aspects of design and...
What is EU IVDR? A Detailed Introduction (and Role of eQMS)

What is EU IVDR? A Detailed Introduction (and Role of eQMS)

by Allan Murphy Bruun | Mar 6, 2023 | Medical Devices, Regulations

The European Union In Vitro Diagnostic Regulation (EU IVDR) is the European law concerning placing in vitro diagnostic medical devices for human use and their accessories on the market. The IVDR was introduced in May 2017 to improve the safety and efficacy of in vitro...
MDSAP: Medical Device Single Audit Program

MDSAP: Medical Device Single Audit Program

by Allan Murphy Bruun | Feb 10, 2023 | Audits, Medical Devices

The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of multiple regulatory authorities. Audits are conducted by Auditing...
CE Marking for Medical Devices [Step-by-Step Guide]

CE Marking for Medical Devices [Step-by-Step Guide]

by Allan Murphy Bruun | Dec 22, 2022 | Medical Devices

To sell and market your medical device across the European Union (EU), you must have a CE marking of conformity. Manufacturers of medical and in vitro diagnostic devices that wish to be part of the European Economic Area market must adhere to regulatory...
What is a Device History Record (DHR) and Why is it Important?

What is a Device History Record (DHR) and Why is it Important?

by Germans Frolovs | Sep 7, 2022 | Medical Devices

The complete documentation about the manufacturing and tracking of every medical device that your company sells is contained in a Device History Record (DHR). As per current international regulatory guidelines, your medical device company must maintain DHRs (or...
Medical Device Technical File and Its Structure

Medical Device Technical File and Its Structure

by Germans Frolovs | May 16, 2022 | Medical Devices

As a medical device manufacturer planning to sell your devices in the European Union (EU) market, you will first need to demonstrate compliance with EU regulatory requirements. You will ascertain this conformity by preparing meticulous information about the design,...
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