We assist manufacturers in preparing technical documentation for submission to EU notified bodies and national regulatory authorities to certify their medical devices in compliance with Medical Devices Regulation (EU) 2017/745. Our team has an excellent record in preparing documentation that successfully passes the certification process. Additional services include notification and follow-up with national competent authorities and notified bodies.
We prepare and deliver technical documentation required for the certification of your devices on the EU market, including the Risk Management File (RMF), Clinical Evaluation (CER), Post-Market Clinical Follow-Up (PMCF), Post-Market Surveillance Plans and Reports (PMS), Periodic Safety Update Reports (PSUR), and Biocompatibility Assessment Reports. We involve a clinical expert in the relevant field as appropriate.
- Review, revision, and complete preparation of all parts of technical documentation required for successful certification of medical devices in the European Union
- Preparation of Risk Management File in compliance with ISO 14971:2019 and Medical Devices Regulation (EU) 2017/745
- Screening of scientific literature for Clinical Evaluation Reports (CERs) and Biological Compatibility Assessment Reports (BCARs)
- Preparation of Biological Compatibility Assessment Reports (BCARs) in compliance with ISO 10993-1:2018
- Preparation of clinical documentation, i.e., Clinical Evaluation Plan and Report
- Design of PMCF studies, preparation of Post-Market Clinical Follow-Up (PMCF) Plan and Report
- Post-Market Surveillance Plan and Report
- Periodic Safety Update Reports
- Suggestions for revision of Instructions for Use and other informational materials
- Preparation of internal training materials and processes to facilitate the transition to in house follow-up and maintenance
Our Team has an exceptional record of successful submissions.
- Strategy closely coordinated with manufacturers
- Experienced team of highly trained professionals
- Access to multiple medical specialties
- Full-spectrum of required documentation
- Attentive and professional staff with a can-do attitude
- Extensive knowledge of the regulatory environment
