Medical Device Validation Delivery

Explic8 Limited assembles team of validation SMEs

The introduction of increasingly rigorous regulations such as EU MDR 2017/745 and IVDR 2017/746 means that it is now a legal requirement for medical device manufacturers to validate their products and processes. It is no longer sufficient to utilise verification instead.

The legacy or “grandfather” principle is no longer acceptable so even if a product has been on the market for years it must now be validated.

Validation is the process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in design, testing and serial production maintains the desired level of compliance at all stages.

Explic8 has assembled a team of SMEs in each of the following validation arenas:

  • R&D Validation (Design validation, Product specification & DFMEA)
  • Process Validation (IQ, OQ, PQ, PPQ, Calibrations, PMs)
  • Packaging Validation
  • Purchased Components Validation
  • Incoming Inspection TMVs
  • Testing Laboratory TMVs
  • Facilities / Maintenance Validation
  • Clean Room Validation
  • QMS Validation
  • Software (CSV) Validations

Explic8 Limited consultants can support your organisation’s validation processes and implementation, improving compliance and efficiency while reducing cost and complexity.