MENU 
CORE SERVICES
EU AR / PRRC Services
We will be your PRRC or EU AR under the new EU Medical Device and In-Vitro Diagnostic Regulations.
EU Authorised Representative
EU Market Access
We can help you successfully CE Mark your device under the Medical Device Regulation and In-Vitro Diagnostic Regulation
FDA Regulatory Submission
We can be your guide for clearance/ approval of your device in the US under the 510k, PMA or De Novo routes.
ONGOING AND ROUTINE SERVICES
Review and approval of all elements of Medical Device and IVD submission data (CE mark & US FDA) including the following:
- Define your product and develop your regulatory strategy
- Liaison with Notified Bodies and Competent Authorities
- Assessments against new EU Medical Device / IVD regulations (2017) to assist with transition to new requirements
- Design control (verification & validation)
- Design file compilation
- General Safety and Performance Requirements (GSPRs) checklist
- Risk management analysis (ISO 14971:2019)
- Patient information management (IFU, labelling and Cartons)
- Device classification & predicate device searches (US)
- Unique Device Identification (UDI) & Global Unique Device Identification Database (GUDID)
- Cybersecurity and GDPR
- Sterilisation validation report
- Clinical Evaluation Reports (medical devices) / Performance Evaluation Reports (IVDs)
- Investigator's brochure
- Patient consent
- Review of summary of pre-clinical data etc
- Advice, guidance and implementation of all mandatory standards, such as ISO 13485:2016 (Quality Management Systems)
- Internal audits, vendor audits, quality and regulatory compliance audits
- Technical file compilation
- Submissions/registration management
- Follow-up meeting to discuss & resolve Q&A from submissions & registrations
- Adverse events monitoring & reviews including devices undergoing clinical investigation
- Review & management of product recalls
Rest of World regulatory and quality compliance expertise is provided by our parent company, Global Regulatory Services (GRS).
