Medical device consulting: ProtomedLabs is a certified single source supplier for all device testing needs. We offer engineering support in medical device testing to help manufacturers comply with regulations and directives, and bring medical devices to market. We offer medical device consultingservices in 3 areas in relation to device testing: Preparation for device validation testing, progressive device testing integration, and legal proceedings support.
STANDARD AND GUIDELINES REVIEW, ANALYSIS AND INTERPRETATION
ProtomedLabs provides support to medical device manufacturers in relation to test standards and guidelines review analysis and interpretation. Directives require that safety and performance tests be conducted on products before human use.
RATIONAL DEVELOPMENT FOR TEST PARAMETERS AND ACCEPTANCE CRITERIA
ProtomedLabs provides support to help engineers determine test parameters and their acceptance criteria. Test parameters and their acceptance criteria can be derived using engineering expertise in physiology, biomechanics and fluid mechanics complemented by references from publications.
SAMPLE SIZE DETERMINATION
Most standards and guidelines do not provide recommendations regarding the sample size. Our engineers can help device manufacturers develop sample size justifications before engaging in any test activities in relation to validation work and submission.
PROTOCOL DEVELOPMENT AND TEST PLAN OPTIMIZATION
Protomedlabs provides support to develop protocol for device testing in compliance with applicable standards and guidelines. Protocols can be designed to respond to evaluation requirements at any stage of the device development process.
PRODUCTION EQUIPMENT VALIDATION AND TEST EQUIPMENT VALIDATION
ProtomedLabs provides support to manufacturers to prepare and carry out production and test equipment validation work. Validation can guarantee that equipments operate within specific known limits and that the output complies with predetermined requirements in order to improve overall product quality and reduce cost. Validation can be conducted on a wide range of equipment used both in production room, QA and R&D laboratories.
DEVICE TESTING INTERNALIZATION SUPPORT
A fully integrated certified laboratory like ProtomedLabs, which can cover all the tests needed for cardiovascular medical devices, can be better suited to run comprehensive test programs and highly specific test activities to reduce overall R&D cost. On the other hand, internal integration of some testing activities can also accelerate R&D development cycles, reduces program failure risks, increases device confidence and reliability levels, improves regulatory path and optimizes validation time.
MEDICAL DEVICE LEGAL EXPERTISE
ProtomedLabs can provide expertise to attorneys and persecutors when medical device manufacturers are faced with legal proceedings. Our engineers can provide expertise to review, analyze, and interpret test standards and guidelines in order to determine test requirements and adequate test methods to be used. Independent third party device performance testing can be conducted on test samples to determine whether or not devices comply with regulatory standards and guidelines.