Building a Compliant QMS Under EU MDR
Establishing a robust Quality Management System (QMS) is a cornerstone of regulatory compliance for medical device manufacturers operating in the European Union. The EU Medical Device Regulation (MDR) (Regulation (EU) 2017/745) requires every manufacturer to implement and maintain a QMS covering the entire lifecycle of their devices—from design and development through post-market activities. While the ...
Who Needs Quality Management Systems (QMS) under Regulation (EU) 2017/745 (MDR) and does it need to be ISO13485 Accredited?
The simple answer is all manufacturers must have a quality management system to comply with the MDR and in compliance with Article 10 (9). However, as with much of the MDR, if only it was that simple. In an excerpt of Article 10 (9) it states: ‘Manufacturers of devices, other than investigational devices, shall establish, ...
QMS Services
A Quality Management System (QMS) is the backbone of the design, production, and management of medical devices. It is now mandatory for all medical device manufacturers to have a quality management system (QMS) in compliance with Article 10 of the MDR/IVDR. Article 10 of both the EU Medical Device Regulation 2017/745 (MDR) and the EU ...
Internal Audits
In accordance with ISO 13485:2016 clause 8.2.4 and 21CFR820.22, a Medical Device Manufacturer’s Quality Management System must be audited in accordance with a documented procedure which must be completed impartially by competent personnel. To help our clients remain compliant, here at Advena we offer a service whereby we can perform an internal audit via desktop ...
Why is Quality Management important?
The need for some form of a Quality Management System (QMS) has been a long-term requirement for Medical Device manufacturers. Under the old regulations a certified Quality Management System was not specifically required for lower risk Medical Devices but manufacturers have always been obliged to have a manufacturing control function, and related procedures and records, ...
