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CAP COMPLIANCE – Your Expert in Regulatory Affairs and CE Marking for Medical Devices

 

CAP COMPLIANCE is a consulting firm dedicated to manufacturers of medical devices and in vitro diagnostic medical devices, specialising in regulatory support, training, auditing and compliance with current requirements. Our mission is to support you at every key stage of regulatory management, from the implementation of quality management systems to obtaining the CE marking, while ensuring continuous adaptation to evolving standards.

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We work closely with medical device manufacturers to ensure that their products meet the requirements of the health authorities, while facilitating their access to the market as quickly as possible. Thanks to our expertise in regulatory affairs, auditing, training and consulting, CAP COMPLIANCE helps you navigate a complex regulatory environment.

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Our Consulting, Auditing and Training Solutions for Medical Device/In Vitro Diagnostic Medical Device Manufacturers

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We offer a full range of services tailored to meet the specific needs of MD/IVDMD manufacturers, covering compliance management and best practice training.

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• Regulatory Affairs Consulting: Development of strategies tailored to your medical device development project, follow-up of CE marking files, post-market PMS and PMCF follow-up and support in managing relations with health authorities. We ensure that your products comply with local and international regulatory requirements.

• Management of Quality Management Systems (QMS): Implementation and continuous improvement of quality management systems according to the ISO 13485 standard.

• Design support: We are approved for the "Crédit d’impôt innovation".

• Internal Audits and Suppliers: Conducting internal audits to assess the compliance of your activities and your suppliers. We also assist you in preparing for inspections by the authorities and certification audits, in order to ensure the sustainability of your medical devices on the market.

• Training and Awareness: Tailor-made training programmes for your teams, focusing on regulatory affairs, CE marking, and good quality management system practices. Thanks to our QUALIOPI certification, you can benefit from financial support for these training courses.

• Regulatory Monitoring and Compliance: Monitoring of regulatory developments to ensure that your practices and documents are regularly updated so that your medical devices remain compliant with new legal requirements. Carrying out a Gap Analysis..

• Interim Management: Provision of highly qualified ad hoc resources.

• Provision of Resources: Quality and Regulatory Affairs Manager, Quality Manager, monitoring of critical suppliers, post-market monitoring, etc.

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Specific Support for Medical Device Manufacturers

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In addition to our main consulting and auditing services, we offer support to meet the specific needs of medical device manufacturers and healthcare companies.

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• Advertising and Communication: Verification of the compliance of your advertising communication media with current regulations, to guarantee responsible promotion of your products.

• Compliance with the Anti-Gift Law (Loi Anti-Cadeau): Support in the management of benefits offered to healthcare professionals, in accordance with current legislation.

• Transparency of Professional Relations: Implementation of procedures guaranteeing transparency in interactions between your company and healthcare professionals, in accordance with regulatory requirements.

• HAS (French National Authority for Health) Guidelines for the Promotion of Medicines: Assistance in complying with the standards of the French National Authority for Health (HAS - Haute Autorité de Santé) for medical devices and the promotion of medicines, in order to meet the sector's rigorous criteria.

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Why choose CAP COMPLIANCE?

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• Recognised expertise: Our specialists have in-depth knowledge of local and international regulations.

• Personalised approach: We adapt our services to your specific needs for optimal management of your medical devices.

• Commitment to quality: We are committed to providing high-quality solutions to guarantee the safety and effectiveness of your devices.

• Approved as ‘medical device experts’ by the BPI (Banque Publique d'Investissement): You can benefit from financial support to help you obtain CE marking or set up your quality management system (parts 1 and 2).​

 

Join the many customers who already place their trust in us and simplify the management of your medical devices with CAP COMPLIANCE.

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Contact us today to find out more about our services and how we can help you achieve your compliance objectives.