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:

  • QMS implementation for small high-growth medical device companies
  • QMS administration and management for small high-growth medical device companies
  • Audits to QSR 21 CFR Part 820 for medical device companies
  • FDA QSR training
  • ISO 13485 training
  • Audits to ISO 13485 for medical device companies
  • QA and RA due diligence audits of medical device companies
  • Quality assurance regulatory affairs and clinical affairs outsourcing
  • Medical Device Single Audit Program (MDSAP)
  • Transition from ISO 13485:2003 to ISO 13485:2016
  • Spreadsheet Validation

Case Studies:

Design Control Document Templates
Due Diligence
Large Company QMS Harmonization