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. Test offered through our FAST TRACK will be based on 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 depending on our work load and the number of samples to be processed.  Any formal reporting on medical device performance requires at least a STANDARD SERVICE level.  Any test conducted in relation to regulatory submission work requires a FULL SERVICE level.

Deliverables for FAST TRACK, TRK, test service include: a basic test sheet and raw data only.  The following services are not included in the Fast Track – TRK test service: Detailed protocol, final report, data analysis, data interpretation, detailed test method description, and relevant statistical analysis. All documents and communication will be provided in English.

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. Any formal reporting on medical device performance requires at least a STANDARD SERVICE level.  Any test conducted in relation to regulatory submission work requires a FULL SERVICE level.

Deliverables for STANDARD SERVICE, STD, test service include: basic protocol based on applicable standards without rationales, basic report with data post processing and deviations, test method description, and apparatus. The following services are not included in our STANDARD SERVICE, STD, test service: comprehensive protocol with rationales, comprehensive final report, data interpretation/analysis against acceptance criteria, and relevant statistical analysis. All documents and communication will be provided in English.

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 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 test services proposed by ProtomedLabs. Study plan with anticipated delivery date will be provided upon starting the complex large studies involving several tests (more than 4 tests), or test stretching over a long period of time.

Deliverables for FULL SERVICE, FLL, test service include: comprehensive protocols, data interpretation/analysis against acceptance criteria, test method description and apparatus, relevant statistical analysis and comprehensive final report in compliance with applicable standards and deviations. The following services are not included in our FULL SERVICE, FLL, test service: GLP compliance with 21 CFR Part 58 and specific statistical analysis (based on demand only). All documents and communication will be provided in English.  Note: Only accredited tests which fall within the scope of the current certificate (*scope available on www.cofrac.fr) are compliant with ISO 17025:2017 and bear the ISO 17025:2017 certificate as textual reference.

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 US GLP guidelines (21 cfr part 58).  Full compliance with Good Laboratory Practices (GLP) for Non-Clinical Laboratory Studies 21 CFR Part 58 guidelines can provide additional guarantees on top of ISO17025:2017 accredited tests. GLP compliance is available on most if the test services offered by ProtomedLabs, exceptions may apply. 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. Study plan with anticipated delivery date will be provided upon starting the complex large studies involving several tests (more than 4 tests), or test stretching over a long period of time.

Deliverables for FULL SERVICE W/GLP, FLG, test service include: comprehensive protocols, data interpretation/analysis against acceptance criteria, test method description and apparatus, relevant statistical analysis and comprehensive final report with deviations in compliance with applicable standards, and a compliance certificate with GLP requirements 21 CFR Part 58. The following services are not included in our FULL SERVICE W/GLP, FLG, test service: specific statistical analysis (based on demand only). All documents and communication will be provided in English.  Note: Only accredited tests which fall within the scope of the current certificate (*scope available on www.cofrac.fr) are compliant with ISO 17025:2017 and bear the ISO 17025:2017 certificate as textual reference.

ProtomedLabs – Medical device testing Service Levels