We support our clients through all stages of a product’s lifecycle, from preclinical assessment
to pre-market clinical trials, all the way to CE marking and post-market surveillance activities.
In the area of CE marking we cover a wide range of devices under Regulation (EU) 2017/745
on medical devices and 98/79/EC on in vitro diagnostic devices.
Our regulatory services include:
Qality Management System documentation based on ISO 13485
Review of the existing technical file
Gap analysis for compliance with new Regulation 2017/745 on Medical Devices (MDR) and new Regulation 2017/746 on In-Vitro Diagnostic Devices (IVDR).
Regulatory strategy for CE mark: device classification, identification of applicable requirements, technical standards, preclinical and clinical studies for CE marking according to MDR and IVDR.
Notified Body selection and Interaction with Notified Bodies and Competent Authorities during certification processes.
Technical documentation preparation and maintenance (Technical File/Design Dossier) .
Product’s leaflet and labels texts preparation and review.
Clinical Evaluation File according to MEDDEV 2.7.1 Current Edition and MDR.
Post Market Surveillance (PMS, PSUR).
Post Market Clinical Follow-up (PMCF).
Post Market Vigilance (PMV).
Support to Company’s Risk Management Team for medical device risk analysis according to ISO 14971 current version.
Support for Biological Evaluation for biocompatibility tests planning.
CTD for drug substance and drug product for combination products (drug- medical device).
EUDAMED Registration and UDI code support.
To learn more about what we can do for you, drop us an E-mail