Medical Device submission data for EU

CORE SERVICES

We will be your PRRC or EU AR under the new EU Medical Device and In-Vitro Diagnostic Regulations.

We can help you succsessfully CE Mark your device under the Medical Device Regulation and In-Vitro Diagnostic Regulation

We can be your guide for clearance/ approval of your device in the US under the 510k, PMA or De Novo routes.

Review and approval of all elements of Medical Device 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
Essential requirements/General Safety and Performance requirements checklist
Risk management analysis
Patient information management (IFU, labelling and Cartons)
Device classification & predicate device searches (US)
Unique Device Identification (UDI) & Global Unique Device Identification Database (GUDID)
Sterilisation validation report
Clinical evaluations
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).