Regulatory
Medical Devices
All your scientific, technical and legal regulatory needs in one place.
Services
Regulatory Strategy
- Preliminary advice on the project and its regulatory framework.
- Regulatory legal consultancy, personal data protection, legal support in clinical trials.
- Monitoring, Sanctions and Litigation.
We guide you in your regulatory process
- Regulatory strategy and Roadmap
- MD/MDSW/IVD classification
- RUO (Research Use Only) product consulting
- Design, implementation and maintenance of the Quality System (ISO 13485, ISO 15189…) and assistance in audits.
- Preparation of the technical file for MD/MDSW/IVDs
- Advice and assistance in the application of the CE marking before the Notified Body in the EU and follow-up of queries or requirements.
- Advice on import and export of MD/MDSW/IVDs
- Processing of prior licenses as manufacturer or importer of MD/MDSW/IVDs.
- Product registration in LATAM countries.
- Registration and/or update in EUDAMED
- Support in procedures related to the UDI
- Support on market surveillance related requirements
- Review of labeling, IFU and promotional materials
- Scientific-technical and legal advice