QMS

Set up, implement and/or modify your Quality Management System (QMS) according to ISO13485

Regulatory Affairs

Support you in your regulatory process (CE marking, FDA)

Audit assistance

Support you during notified body audits or guide you in auditing your subcontractors

Interim QA/RA

Act as your Quality Assurance or Regulatory Affairs manager

Contact Us

QA/RA consulting for medical devices

Ruth Beckers

rbe@qualix.be
+32 495 414 464
Vooruitgangstraat 47
B-1210 Brussels