Quality Management System (QMS)

The quality management system (QMS) as a duty for every medical device manufacturer

Manufacturers of medical devices must have a quality management system (QMS). The establishment and maintenance of QMS were originally based on the DIN EN ISO 9001 standard. Since 2003, the harmonized DIN EN ISO 13485:2012 standard commissioned by the EU Commission has been in force. In Europe, the QMS of medical device manufacturers are certified by state Notified Bodies. For the US market, the quality management system (QMS) has to conform to the FDA regulations (Quality System Regulation 21 CFR 820) as well as to the ISO 13485: 2016.

After initial certification, annual repeat audits by the Notified Bodies/take place, followed by certification audits every five years at the latest. If successful, the notified body issues a certificate of conformity. Only this certificate entitles the manufacturer to issue the declaration of conformity and to affix the CE marking to his product.

With the establishment of the QMS, we also integrate Good Manufacturing Practice (GMP) requirements. Likewise, the system should be quickly integrated into the daily routine so it can support the management of the company. Pharma Expertise Consulting offers an audit service to ensure that medical devices meet the specified quality requirements. We also undertake qualification and auditing of suppliers and contract manufacturers, self-inspections of medical device manufacturers, and simulate unannounced audits of Notified Bodies in order to check and continually improve existing processes.

We help you comply with the relevant quality requirements to market your medical devices. Feel free to contact us!