Medical Device

We can support you with:

  • Quality Strategies and projects
  • QMS implementation and improvements (GMP/GDP/ISO13485)
  • Audits- GMP/GDP/ ISO13485
  • Audits- internal, supplier, joint audits, mock-audits
  • Inspections- preparations before inspections from authorities
  • Risk assessments, ISO 14971
  • GAP-analysis and CAPA plans
  • CAPA management
  • Life cycle management, e.g. change control, PMS, complaints, deviations
  • Quality agreements
  • Training programs, GMP/GDP/ ISO13485
  • Regulatory Affairs Market access and registrations
  • MDR, MDD
  • GSPR
  • IEC 60601 family

We can also provide other services, please contact us for a discussion on how we can help you.