Med-Di-Dia

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TIME CRITICAL SERVICES

Person Responsible for Regulatory Compliance

 

For micro and small companies, we will be your Person Responsible under the new EU Medical Device and In-Vitro Diagnostic Regulations.

 

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Authorised Representative

 

For non-EU and UK companies, we can be your Authorised Representative within Europe.

 

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Legal Representative for EU Clinical Trials

 

For UK organisations running EU-wide clinical trials, we will be happy to act as your Legal Representative to ensure continuity of your trials post-Brexit at a minimal cost.

 

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ONGOING AND ROUTINE SERVICES

 

Review and approval of all elements of Medical Device submission data (CE mark & 510(k)) 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).