SERVICES
Clinical Evaluation Reports
We specialise in clinical evaluation report writing. Our team can help you prepare reports that meet the regulatory requirements required to conduct Clinical Evaluation, such as the EU Medical Device Regulation (MDR) and the relevant guidance from the Medical Device Coordination Group (MDCG).
Periodic Safety Update Reports (PSUR)
We offer periodic safety update report (PSUR) services to help you meet the regulatory requirements for safety monitoring of medical devices. Our team of experts has extensive experience in PSUR preparation and can assist you in preparing reports that meet the relevant regulatory requirements, including the Medical Device Coordination Group (MDCG) guidance.
Post Market Clinical
Follow-Up (PMCF)
We offer a service to help you assess the compliance of your marketing claims and identify data to support those claims. Our team of experts has extensive experience in evaluating marketing claims and can assist you in developing compliant claims that are supported by reliable data.
Summary of Safety and Clinical Performance (SSCP)
We provide comprehensive SSCP services to help manufacturers of Class IIb implantable and Class III devices comply with EU MDR requirements and demonstrate the safety and clinical performance of their devices. Our services are aligned with the guidance provided by the Medical Device Coordination Group (MDCG) and are designed to meet the highest standards of quality and accuracy.
Post Market Surveillance Plans
We understand the importance of post-market surveillance in ensuring the safety and efficacy of medical devices. That's why we offer Post Market Surveillance Plan (PMSP) services that help you meet regulatory requirements, including Article 83 of EU MDR, and proactively collect data to ensure continuous product improvement.