We frequently encounter documentation issues related to clinical and performance evaluations within technical files, and examples are:
No clinical/performance plan, or if there is a plan, it does not comply with current requirements.
There is no reliable methodology or protocol for conducting literature searches that would allow for the search to be repeated.
Literature review is not comprehensive or accurate, leading to incomplete and incorrect analysis, potentially impacting the evaluation of the medical device’s safety and effectiveness.
Lack of data analysis to demonstrate conformity with relevant General Safety and Performance Requirements (GSPRs) and or Essential Requirements Checklist (ERC) such as performance, safety, and benefit-risk ratio acceptability.
Absence of robust Post Market Surveillance data, annual PSUR as applicable, including sales summary, complaints, and available clinical data (if applicable).
To avoid common mistakes, you must prepare your clinical or performance evaluation documentation in accordance with relevant regulations and available guidance, such as MDCGs and Meddevs. Your internal procedures should also align with regulatory requirements and current business practices to facilitate the creation of evaluation documentation.
If you need expert support and guidance with clinical performance evaluation documentation, contact us today at (email address here) or complete the Contact Us form. Our consultancy services are tailored to meet your needs at competitive and cost-effective rates.
