Much of medical device testing revolves around device cleaning and sterilization to ensure the safety of patients who will use the device.
Medical device testing is of major importance to companies and manufacturers as a device failure can cost the company hundreds of thousands of dollars. Medical device testing helps to ensure kinks or vulnerabilities are worked out before the device reaches the general public. Besides testing to ensure the device functions as expected, much of medical device testing revolves around device cleaning and sterilization to ensure the safety of patients who would use the device.
Cleaning of medical devices ensures they meet industry regulations and standards. The FDA has created specific cleaning procedures to ensure all medical devices meet the same cleanliness guidelines as any foreign substance or residue on a medical device can cause the implant to fail or introduce microorganisms to the patient. These guidelines require that all residues on a device be identified and limits set for acceptable levels. The cleaning standards for devices are required to then reduce the number of residues to below-acceptable levels. Documentation proving levels are below acceptable limits must be submitted to the FDA before the device is cleared for use by the public.
Though strict medical device testing standards and cleanliness standards exist, devices are still recalled due to contamination and sterilization issues. Medical device and cleanliness testing includes performance testing to ensure the device functions as expected, biocompatibility testing to identify toxins, and microbiology testing to identify microorganisms.
Test Requests Received by Contract Laboratory
- A Medical Device laboratory is needed for thermal, mechanical, and dynamic analysis to support the development of a new transdermal patch. Studies to include: Rheology measurements on native adhesive and the drug-in-adhesive formulation to assess changes in the visco-elastic properties of adhesive, Elastic or storage modulus, Viscous or loss modulus, Ratio of viscous to elastic modulus, Intrinsic or complex viscosity
- FDA cGMP medical device laboratory is needed for condom compatibility testing following FDA guidelines.
- Laboratory needed for testing orthopedic products: medical bone screws, angled orthopedic fracture fixation device, external skeletal fixation device, and bone plates. ASTM F543 Annex A1, A2, A3 / ASTM F384 Annex A1, A2 / ASTM F382 Annex A1, A2 / ASTM F1541 Annex A5 and ISO 10334 or ISO 5838-1.
- Medical device/materials laboratory needed for ASTM testing of personal protective equipment/gloves to ASTMF2878-10 (Needle Stick Test)
- Biomechanical/medical device laboratory needed for the development of spinal implantable device manufactured with implantable grade PEEK and Titanium 3. The following testing is required: Slippage test, Load bearing test, Compression Test, Bio-Compatibility test
- Medical Device company needs a physical chemistry laboratory for surface tension and surface energy testing
- ISO 17025 medical device laboratory needed for cleaning/sterilization validation testing on bone fixture medical devices.
- A medical device safety laboratory is needed for biocompatibility testing of medical devices.
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