QMS Compliance & Auditing

QMS-ComplianceAlvaMed is a Quality Management System (QMS) consulting and outsourcing company serving the medical device industry. We help you recognize when you first need a QMS, then our experts work closely with you to develop, install, and manage your QMS. AlvaMed has helped more than 50 clients install and manage their QMS including our participation to support the auditing of the QMS by FDA and Notified Bodies. AlvaMed is ISO 13485 certified – we practice what we preach. For larger companies we harmonize multiple quality systems into a single system, more resilient to external review and increasing intra-site communication.

Services Offered:

Case Studies:

Design Control Document Templates
Due Diligence
Large Company QMS Harmonization