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Consulting

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Our advice and support services

At Cap Compliance, we support stakeholders in the medical device and in vitro diagnostic medical device sector in regulatory and normative compliance. Thanks to our in-depth expertise, we provide you with strategic and operational advice tailored to your specific needs.

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Support in quality management systems

We guide you in the implementation and improvement of your processes according to the standards in force:

  • ISO 13485 Quality Management System - Medical Devices

  • MDSAP Medical Device Single Audit Program

  • ISO 42001 Management System - Artificial Intelligence

  • ISO 27001 Management System - Information Security

  • ISO 9001 Quality Management

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Preparation for regulatory inspections/audits of notified bodies:

  • Navigate through regulatory authority inspections and certification audits with confidence thanks to our expert support.

  • In-depth review of your quality systems and technical files to identify potential discrepancies and prepare for inspections/audits according to regulations (EU) 2017/745 and 2017/746.

  • Compliance audits: Internal and mock audits to assess the compliance of your QMS with ISO 13485 and the requirements of European regulations.

  • Training of your employees on the requirements of Regulations (EU) 2017/745 and 2017/746 and best practices to respond effectively to auditors or inspectors.

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Support with the design of your medical devices

We support you throughout the development cycle of your medical devices, integrating regulatory and normative requirements from the earliest stages. Thanks to our Crédit d’Impôt Innovation (CII) accreditation, we help you optimise your R&D investments and benefit from an advantageous financial framework for your innovative projects.

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Our expertise in design:

✅ Development and industrialisation: From idea to prototype, we help you structure your projects by integrating good design practices and regulatory requirements (ISO 13485, MDR, IVDR).

✅ Risk management (ISO 14971): Identification, evaluation and control of risks related to your devices to guarantee their safety and efficiency.

✅ Biocompatibility and clinical performance: Validation of materials and biological interactions in accordance with current standards.

✅ Technical documentation and CE marking: Assistance in the drafting of technical files for compliance with European and international requirements.

✅ Integration of cybersecurity: Support for design, development and maintenance, for devices that are secure against digital threats.

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Preparation and review of technical files

We assist you in the compilation and optimisation of your technical files to ensure their compliance before submission to notified bodies.

  • Medical Devices

  • In Vitro Diagnostic Medical Devices

 

Outsourcing of your Quality and Regulatory function

We offer flexible outsourcing solutions to provide you with quality and regulatory expertise tailored to your specific needs.

  • Outsourced quality management: Provision of a quality consultant to manage your QMS and ensure the compliance of your medical devices.

  • Support during periods of overload: Reinforcement of your quality and regulatory teams during critical periods or periods of activity overload.

 

Regulatory and standards monitoring

Our team proactively monitors regulatory and standard developments to guarantee you flawless compliance. We offer to decipher new texts, update your monitoring tables and carry out precise gap analyses.

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Cybersecurity of medical devices

In the face of the growing challenges of IT security, we help you put in place appropriate measures to protect your devices and sensitive data.

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Biocompatibility

We advise you on the requirements and strategies to adopt to demonstrate the biocompatibility of your medical devices.

 

Post-market surveillance and vigilance

We support you in the implementation of an effective post-market surveillance system, in accordance with the regulatory requirements in force.

We support you in the drafting of the following documents:

  • PMS plan and report

  • PSUR plan and report

  • PMPF plan and report

  • PMCF plan and report

 

Medical visit charter for medical devices and medicines

We support you in the application of the medical visit charter for medicines as well as the future medical devices charter, by offering you customised audits or the implementation of a system adapted to your needs.

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Review of promotional material for medical devices and medicines

We help you ensure the regulatory compliance of your promotional materials and respect the legal obligations relating to medical communication.

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Person Responsible for Regulatory Compliance (PRRC) Service

We offer specific support for the provision of a Person Responsible for Regulatory Compliance (PRRC).

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Consulting Subscription

Benefit from personalised support and access to our experts for all your regulatory and normative questions.

 

Why choose Cap Compliance?

✔ Specialised expertise in the field of medical devices.

✔ Our experts are qualified by product code as notified body auditors/assessors.

✔ Tailor-made support according to your needs and constraints.

✔ High flexibility to adapt to your requests and deadlines.

✔ Full support from defining product positioning to implementing solutions, we support you at every stage of your quality and regulatory process.

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📩 Need support, an audit or training? Contact us to ensure your compliance with Cap Compliance.

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