Verification & Validation

Medical Murray can perform the necessary design verification and design validation testing to assure your device is safe, functions as intended, and is ready for regulatory submission.

Design Verification

Design Verification (DV) consists of testing a medical device to collect objective evidence that the design outputs meet all of the predetermined design inputs and regulatory requirements. Ultimately, Design Verification provides assurance that the device is safe, functions as intended, and is ready for clinical use and/or regulatory submissions. 

Design Verification support at Medical Murray commonly consists of the following: 

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  • Design FMEA
  • Design Verification Protocols
  • Device Master Record Documentation
  • Process Validation Planning
  • Packaging Validation and Report
  • Bench Testing and Report(s)
  • Cleanroom Assembly and Packaging
  • Sterilization Validation (EO, Gamma, or eBeam)
  • Ethylene Oxide Validation Adoption
  • Biocompatibility Testing and Reports
  • Shelf Life Validation (Accelerated & Real Time)
  • Compiling Regulatory Submission Documents (IDE, 510k, PMA, CE Marking)
Surgeons Preparing Equipment For Surgery Helping Each Other In Operating Theatre
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Surgeons Preparing Equipment For Surgery Helping Each Other In Operating Theatre

Design Validation

While Design Verification demonstrates that the medical device meets the engineering requirements, Design Validation demonstrates the device addresses the User Needs when put to use. According to the FDA, Design Validation is confirmation by examination and provision of objective evidence that the particular requirements for a specific use can be consistently fulfilled.

For the interventional products produced at Medical Murray, clinical evaluation is often necessary to validate the design. Design Validation support at Medical Murray commonly consists of the following: