Medical Devices - ClarkeModet

Regulatory

Medical Devices

Medical Devices regulatory landscape is complex due to the great diversity of the products and has to be addressed in order to maintain a competitive position in the market. We provide specialized support for medical devices (MD), medical device software (MDSW), and in vitro diagnostics (IVD), ensuring compliance with current regulatory frameworks and quality standards. Our solutions cover the entire product lifecycle, offering comprehensive and tailored support from design and development to achieving CE marking and successful commercialization.

Medical Devices Solutions

Technical regulatory solutions

MD/MDSW/IVD classification
Preparation of the regulatory strategy and roadmap in the preclinical and clinical phases to obtain CE marking. Regulatory assessment.
GAP analysis and regulatory strategy.
Advice related to preclinical and clinical aspects.
Preparation of clinical evaluation and technical dossier and for MD/MDSW/IVD.
Advice and assistance in the application for CE marking before the Notified Body in the EU and follow-up of consultations or requirements.
Advice on import and export of MD/MDSW/IVD.
Support in post-marketing activities

Medical Devices Solutions

Quality solutions

Design, implementation and maintenance of Quality System (ISO13485, ISO14971…).
Revision and writing of quality objectives, quality policy, quality manual.
Revision, drafting and implementation of the necessary working procedures.
General and specific training in Quality Standards (ISO13485) or on specific internal procedures and operational practices (CAPA, Complaints, Change Control, Non-Conformity…)
Support for audits (internal audits, suppliers, third parties/partners), revision and writing of technical agreements.
Support and assistance with certification audits, inspections by competent authorities and notified bodies, etc.
Support in the risk management process: risk identification, risk analyses, risk evaluation, risk control.
Support for validations/verifications

Medical Devices Solutions

Legal solutions

Regulatory legal consultancy related to Health Sciences.
Legal support in the development of Clinical Trials (contracts, patient information sheet and informed consent, review of insurance policies, interaction with Clinical Research Ethics Committees, Personal Data Protection in Clinical Trials, subsequent use of personal data for future projects, use of surplus samples for research…).
Legal support in basic research projects (biological samples, biobanks, sample collections).
Legal advice on advertising and promotion of medical devices.
Protection of personal data in the health field
Legal support in sanctioning procedures related to Health Sciences.