Confidence Beyond Compliance

Outsourcing Services: Customized to your needs

The Safis MDS team are experts with many years of experience within the Medical Device Industry and can supply fully outsourced services to increase efficiencies and effectiveness.

Do you need a complete End to End Solution?

We offer the following services:

  • Auditing – Internal & Supplier –  21 CFR Part 820, ISO 13485,
  • GCP, ISO15189, CLIA, CAP, GLP, ISO 17025
  • QMS Integration across business
  • Recall Management
  • QA/RA Due Diligence for Mergers & Acquisitions
  • Computer Software Validations (CSV)
Do you need extra resources as you “Right Size” your organization?

We offer the following services:

  • U.S. Agent/Official Correspondent
  • Interim QA/RA Staffing
  • Complaint Handling Unit