The Peritus Regulatory Medical Device Expert Group has a proud history of over 30 years meeting the QA/RA compliance needs of medical device companies.

We support with a range of medical device clients from start-ups to global multi-nationals on a wide range of projects including:

 ✓  MDD to MDR Upgrade
 ✓  IVDD to IVDR Upgrade
 ✓  ISO 13485:2016
 ✓  CE Marking
 ✓  UK CA Marking
 ✓  Audit Remediation (QMS and Technical Documentation)
 ✓  Market Access: 510k Submissions / MDSAP / ASEAN / Canada / Australia
 ✓  Post Brexit Representation – EU Authorised Representative / UK Responsible Person
 ✓  Internal Auditing (ISO 13485, ISO 27001)
 ✓  FDA Warning Letters / Remediation
 ✓  Software as a Medical Device (SaMD)
 ✓  Digital Health & Cybersecurity
 ✓  UDI (Unique Device Identification)
 ✓  Outsourced Monthly QA/RA Support
 ✓  Bespoke Remote / Onsite Client Training