Advena Pass Re-Certification Audit
We are proud to announce that Advena Malta has successfully passed the ISO 13485 Re-Certification audit with no non-conformities. This significant achievement underscores our commitment to maintaining the highest standards for our clients within the medical device industry. We remain focused on continuous improvement and will continue to prioritise the service we offer to our ...
Advena Malta Passes ISO 13485 Surveillance Audit
We are proud to announce that Advena Malta has successfully passed the ISO 13485 surveillance audit with no non-conformities. This significant achievement underscores our commitment to maintaining the highest standards for our clients within the medical device industry. We remain focused on continuous improvement and will continue to prioritize the service we offer to our ...
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, ...
