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 provide planning to support medical device safety, performance and regulatory compliance. Services include data collection, gap analysis, tailored PMCF plans and regulatory submission support. Its experienced team helps manufacturers meet MDR requirements through structured study design, analysis and reporting processes.
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.
Biocompatibility
We help medical device manufacturers develop clear, proportionate biological evaluation documentation aligned with regulatory expectations. We support evidence reviews, gap assessments, and testing strategies that strengthen technical documentation while prioritising patient safety, compliance, and efficient use of existing data.
Risk Management
We support medical device manufacturers with practical risk management services aligned with ISO 14971 and EU MDR expectations. We help create, review and strengthen risk management files, ensuring they are proportionate to the device and connected to clinical evaluation, PMS, PMCF, usability, software, cybersecurity, biological safety and benefit-risk conclusions. Our approach helps demonstrate that risks are appropriately managed throughout the device lifecycle.
Regulatory Compliance
We provide regulatory compliance support for medical device and IVD manufacturers worldwide. Our consultants develop regulatory strategies, conduct gap assessments, prepare technical documentation and manage global submissions, including CE marking, UKCA marking, FDA 510(k) clearance and PMA applications, helping teams reduce risk, avoid delays and achieve market access.
Sterilisation Validation
We plan and deliver robust sterilisation validation programmes. From strategy and cycle development to microbiological testing, process validation and regulatory submission, we coordinate evidence demonstrating consistent microbial control. Our support covers EO, gamma, e-beam, X-ray and end-user reprocessing, helping protect device safety, performance, packaging integrity and shelf life throughout production and market approval worldwide.
