Medical device testing service levels : ProtomedLabs offers a large selection of medical device testing tailored to meet medical device testing requirements. Our four service levels are designed to provide the exact engineering support needed to efficiently address medical device performance requirements at different stages of the device development process.
Our Levels of Services – Medical Device Testing
TRK – FAST TRACK
Our FAST TRACK level is designed to help engineers in their everyday work and make rapid design decisions. FAST TRACK SERVICE can be used to optimize R&D work ahead of any design lock activity or prototype validation. This minimum test service includes test sheet, raw data only, no final report, no data analysis, and no data interpretation. Test offered by ProtomedLabs comply with ISO or ASTM standards and FDA guidelines. Therefore, test offered through our FAST TRACK will comply with applicable test standards and guidelines without any traceability or proof of compliance. Tests eligible under the FAST TRACK level can be completed within 1-2 weeks or a maximum turnaround time which depends on our work load and the number of samples to be processed. Any formal reporting on medical device performance requires a STANDARD SERVICE level. Any test conducted in relation to regulatory submission work requires a FULL SERVICE level.
STD – STANDARD SERVICE
Our STANDARD SERVICE level is designed to support R&D engineers and cover medical devices development test needs outside regulatory submissions requirements. Standard service can be used to conduct feasibility studies and provide input to properly structure any Verification and Validation (V&V) studies and provide preliminary input on medical device performance. Preliminary performance input can be used to define proper sample size for non-attribute tests. Our standard service includes a basic protocol and basic reports with basic data analysis and no interpretation. Test sheet and test data are provided independently and summarized in the basic reports. Applicable medical device performance tests can be selected from our catalog. A FULL SERVICE level should be used to comply with any regulatory submission requirements.
FLL – FULL SERVICE
Our FULL SERVICE level is offered to cover device Verification and Validation (V&V) test requirements in relation to regulatory submissions. Our most common service offer is designed to address medical device performance issues in depth. Our service includes among other things comprehensive protocols, validated test methods, full traceability on samples and detailed reports in compliance with applicable standards. Our engineers can provide assistance in combining tests to optimize execution time and minimize test samples burn rate. In order to increase chances of success, we recommend conducting a feasibility study to the streamline V&V testing. Full service is available on all tests services proposed by ProtomedLabs.
FLG – FULL SERVICE W/GLP (21 CFR Part 58)
Our FULL SERVICE W/GLP level is offered to cover medical devices Verification and Validation (V&V) requirements in compliance with GLP guidelines (21 cfr part 58). Regulatory agencies and notified bodies in some countries may require additional levels of quality on top of ISO 13485 & 9000 compliance. Full compliance with Good Laboratory Practices (GLP) for Non-Clinical Laboratory Studies 21 CFR Part 58 guidelines can provide additional guarantees regarding facilities, personnel, equipment, standard operating procedures, test and control articles, quality assurance, protocol, records and reports. GLP compliance is available on most tests services offered by ProtomedLabs, exceptions may apply.
ProtomedLabs – Medical device testing Service Levels