Clinical evaluations are unique to each class and medical area. Contact us as we can create a custom set of templates for your unique device needs, QMS system and compliant to your brand identity. We can create:
Full Technical Document template for a Medical Device.
Validation and Verification templates.
Quality Management system SOP's.
Systematic literature review template
Clinical Evaluation CEP and CER template
Post Market Surveillance (PMS plan and PMSR / PSUR): Postmarketing surveillance, also known as post market surveillance, is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance. Post-market surveillance is a set of activities conducted by manufacturers, to collect and evaluate experience gained from medical devices that have been placed on the market, and to identify the need to take any action.
Demonstration of Equivalence
State of the Art
PMCF plans and reports
Summary of Safety and Clinical Performance (SSCP)