Med-Di-Dia

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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 succsessfully 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 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).