Services

Writing of (AI)MDD and MDR compliant Clinical Evaluation Report (CER), Post-Market Clinical Follow-up documents (PMCF), SSCP and Post-Market Surveillance documents (PSUR).

Support for audits and non-conformities related to regulatory submissions and annual surveillance.

Creation and/or update of the quality management system documentation.

Writing of MEDDEV 2.7/1 Rev. 4 compliant literature reviews and State-of-the-Art reviews, including PICO search, selection and appraisal of scientific articles.

Proofreading, analysis and update of the clinical evaluation, post-market clinical follow-up, post-market surveillance and risk management processes for conformity assessment.

Creation and/or optimization of your strategy and your clinical activities, to generate sufficient clinical evidence.

Mid- to long-term planification of the clinical data collection.

Translation, proofreading, data checking, formatting of your quality and regulatory documents.

Lay-language adaptation of scientific and medical information for communication to your patients.