Medical device pre-market submissions depend upon evidence that the device has been qualified to meet the requirements set forth in the design plan. Evidence takes the form of verification and validation reports including:
- Electronic safety testing
- Software and hardware validation
- Bench top and animal testing
- Shelf-life and durability testing
Paladin Medical will:
- Develop and coordinate protocols
- Identify qualified labs
- Set key testing objectives
- Help establish acceptance criteria
- Help with device characterization prior to testing
Pre-Clinical Study Design (GLP, OECD)
Pre-clinical in-vitro and in-vivo (animal) studies must produce results that support product approval submissions and design validation. Animal ethics boards must approve and monitor animal trials. Costs of animal research may exceed the cost of a comparable clinical trial because of extracted device studies and histology.
Our understanding of regulatory requirements and efficient planning experience makes Paladin Medical an invaluable resource to your firm. Not all studies require Good Laboratory Practices (GLP or OECD) compliance, but when it is required, you need a capable facility and someone who serve as your advocate.
For related planning information, please visit the Biomaterials