The Peritus Medical Device Team have extensive experience to be able to support any project from physical medical devices, combinations devices and digital/software applications.

Our Lead Consultant is an accredited as an International Certified Principal Auditor, who has worked with 100s of clients to ISO, FDA, Canadian and CE compliance with the development and improvement of Quality Management Systems (QMS) and Technical Files.

We also have an acknowledged subject quality and regulatory matter expert in mobile health applications. He has gained regulatory recognition for clients Medical Devices from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK, the Health Products Regulatory Agency (HPRA) in Ireland and Food and Drug Administration (FDA) in the USA and many other similar regulatory agencies worldwide.

The team has extensive Software as a Medical Device (SaaMD) experience in USA, Europe and UK.

We have EU Authorised Representative (EU Rep) and UK Responsible Person (UK RP) Services available to clients.

Example projects undertaken include:

• Quality Management Systems (QMS) to ISO 13485:2016 compliance including Class I, IIa, IIb and SaMD
• Technical File Summary Reports to EU MDR 2017/745 and the UK MDR 2002 including Class I, IIa, IIb and Software as a Medical Device (SaMD)
• FDA Submissions for both SaMD and Medical Devices including Traditional 510k, 513g and Enforcement Discretion
• MDSAP Projects, PMS and CER Reports
• Development of supporting documentation for Technical Files such as Risk Management Plans / Hazard Identification / FMEAs / Risk Management Final Reports to ISO 14971:2019
• Essential Requirements Evaluations to UK MDR 2002
• GSPR Evaluations to Annex I of EU MDR 2017/745
• Device classification according to both the EU MDR 2017/745 and UK MDR 2002 including SaaMD
•  Device labelling / artwork including SaMD in compliance with CE and UK CA Marking requirements and ISO 15223:2021
•  UDI / EUDAMED Project Management for device registrations required for European market access
•  EU Authorised Representative (EU Rep) and UK Responsible Person (UK RP) Services
•  NHS Market Access including DTAC, DSPT and DCB0129
•  ISO 13485:2016 Certified Internal Auditor Services
•  GAP Analysis and remedial work to ensure technical documentation compliance with relevant international standards
•  GAP Analysis and remedial work in relation to Notified Body reports following ISO 13485 and/or ISO 27001 Certification or Surveillance Audits