STANDARD AND GUIDELINES REVIEW, ANALYSIS AND INTERPRETATION – Medical Device Validation Testing

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.  Our engineers can provide support:

  • To identify applicable standards and guidelines in order to establish a comprehensive test plan
  • To review standards and guidelines in order to determine differences between newly issued and older versions
  • To develop testing strategies in compliance with applicable standards and guidelines
  • To interpret standards and guidelines in order to identify test requirements and develop adequate test methods

 Test standards and guidelines review analysis and interpretation work is conducted under protocol.  This work is conducted using a fully documented process to comply with most stringent medical device directives and fulfill device validation requirements.

DEVELOPMENT OF RATIONALS FOR TEST PARAMETERS AND ACCEPTANCE CRITERIA

ProtomedLabs provides support to help engineers determine test parameters and their acceptance criteria.  Test parameters and acceptance criteria can be derived using engineering expertise in physiology, biomechanics and fluid mechanics complemented by references from publications.  Literature search is used to identify, rationally select, and collect pertinent information in relation to specific technical, design, pre-clinical and clinical issues.  Literature search is conducted in a way that the method used can be scrutinized by third party reviewers, results provided can be verified, and the search can be repeated and reproduced if required.  Literature search is conducted using a Standard Operating Procedure to properly identify publications database, information sources, and proper key words.  Then a process is used screen and select the specific documents used to develop and build the rational.  ProtomedLabs has developed a proprietary process to search articles from more than 40 databases around the world and provide customers with most up to date references.  Test parameters rationalization can be integrated into any design specification documents, acceptance criteria can be derived from any FMEA studies. 

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 device validation work and submission. Sample size determination must take into account the development stage of the product, production capabilities, and accepted defect risk levels for parameter being studied. Optimum test strategies consist of conducting preliminary device performance assessment before finalizing the design of any devices and before engaging in any full design validation plans.  Feasibility test data, standard deviation, acceptance limits, and risk levels can be all analyzed in order to determine a suitable sampling plan for each test parameters. 

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.  Simple test protocols can be written to address gross device performance issues to fulfill R&D purposes.  Comprehensive test protocols can be designed to comply with regulatory expectations in relation to CE mark, USFDA, or SFDA submissions.  Regulatory agencies and notified bodies in some countries may require addition levels of quality in addition to 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, and laboratory disqualification”. GLP compliance is available on most tests services offered by ProtomedLabs, exceptions may apply. In addition, protocols can be used as tools to identify critical study details that must be layout and addressed prior to planning test activities.  Gaining visibility on test studies allows engineers to understand the impact of the test method used, anticipate potential technical issues, properly plan productions of test samples, and determine overall cost impact of testing. Once protocols are established, sequential and parallel testing can be used in order to optimize execution time and minimize test samples burn rate during testing.  Conducting all tests in one single location improves R&D success rate because test personnel will develop expertise with device handling, and will optimize the use of test samples.

Medical Device Validation Testing – ProtomedLabs