Biomaterials Selection and Biocompatibility Qualification
Paladin Medical helps in the selection and testing of biomaterials. There are no "FDA-approved" biomaterials. However, materials can be selected with a higher potential for successful application in medical device design. These can then be tested to show suitability for use in medical device applications. However, such tests can be expensive and time consuming, and international testing standards can be contradictory. We can identify material suppliers who specialize in medical device applications, and help in selection and testing.
Paladin Medical's experience with ISO-biocompatibility standards will save you time and money. We ensure you only do the biocompatibility testing that is required. We'll help standardize biocompatibility testing, and identify which tests are required when material changes are made. We qualify alternative vendors and develop validation protocols to demonstrate material equivalence.
For specific experience details and project profiles, please see the Paladin Medical Profiles in Success (pdf).
Paladin Medical Key Services
• Development of scientific protocols and research goals.
• Quality assurance requirements, including in-vitro and in-vivo study design.
• Source animal study investigators and qualified testing labs that conform to international quality standards.
• Good Laboratory Practices (GLPs) and OECD standards.
• GLP auditing and training services.
• Selection and testing of biomaterials.
• Source suppliers who specialize in materials for medical device applications, and qualify alternative vendors.
• Biocompatability qualification.
• Protocols to demonstrate material equivalence.
• Shelf-life studies, materials aging, and stability testing design.
©2008 Paladin Medical, Inc.
Qualification Planning and Biomaterials
Qualification Planning
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, Inc. coordinates the development of protocols, identifies qualified labs, sets key research goals, and establishes quality assurance requirements.
Pre-Clinical In-Vitro and Protocol Design
Pre-clinical in-vitro and in-vivo (animal) studies must produce results that support product approval submissions and design validation. Animal ethics boards carefully monitor any animal trial and the cost of animal research may often exceed the cost of a comparable clinical trial. Paladin Medical's understanding of regulatory requirements and careful, efficient planning, makes us an invaluable resource.
