Quality and Regulatory Affairs

Adopting a proactive approach

We understand the challenges you face and help you make informed decisions to accelerate decision-making on quality and regulatory affairs issues related to your market access and sustainability. We offer tailored strategies that make sense for you and the future of your product.

➜ Comprehensive and cross-functional analysis of your organization and product

Strategic QARA advice : methodology and organization

Quality Assurance - QMS | Strengthen and structure your company with quality to demonstrate organizational efficiency and resilience.

➜ Implementation of a Quality Management System (QMS)

Deploying an adapted QMS is a key step in structuring your internal processes and ensuring long-term regulatory compliance. For ISO 13485 compliance :

• Support in structuring processes and the documentation hierarchy : development of a clear framework for your activities.
• Review of documents prepared by your teams : to ensure alignment with the requirements of this standard.

Regulatory Affairs - Technical Documentation
| Demonstrate the safety and performance of your product

➜ Preparation of Technical Documentation

Aligned with European regulations 2017/745 (MDR), 2017/746 (IVDR), and the requirements of markets where you wish to commercialize your medical devices (FDA, etc.).

Technical documentation is at the core of the market entry process for medical devices. We work closely with your teams to structure and draft the essential documents :

• Product development plan
• Risk management file
• Clinical evaluation plan
• Responses and compliance with GSPR
• Product requirements and technical translation of product needs
• Software architecture (if applicable)
• Usability file
• Product-related documentation (manual/instructions for use, labeling, installation instructions, technical description)
• Preclinical evaluation report
• Design validation and verification matrix
• Medical device file (manufacturing instructions)
• Advisory support for CE declarations of conformity and on substances and materials
• Assistance/advice for obtaining codes (MDA, EMDN, UDI, etc.)

We collaborate with our clients through co-writing, reviewing, brainstorming workshops, and an agile methodology, enabling them to master the regulatory requirements, better understand their product, and produce perfectly tailored and compliant documents.

Post-Market Surveillance | Ensure the continuous compliance of your devices
to secure their market presence and strengthen user confidence

➜ Market Maintenance and Certification Renewal

Post-market surveillance and certification maintenance are essential to ensure the sustainability of your operations.

• Development and updates of post-market clinical follow-up plans in collaboration with clinical teams (PMCF/PMPF).
• Drafting of post-market surveillance plans and reports.
• Monitoring regulatory changes (regulatory watch), gap analysis, and implementation of action plans.
• Assistance in managing non-conformities identified during periodic audits.
• Planning and monitoring actions necessary for certification renewal.
• Management of system and product modifications.

Audits | Prepare effectively to ensure compliance,
identify areas for improvement, and meet regulatory deadlines

➜ Preparation and execution of audits

Compliance with ISO 13485, 2017/745 (MDR), and 2017/746 (IVDR) requirements.

Audits are critical steps to demonstrate the compliance of your processes and achieve certification.
We help you anticipate and succeed in these steps through :

Gap analysis (differential analysis) :
Assessment of achievements and gaps relative to the requirements of European regulations and standards.

Internal audit :

• Real-world simulation to prepare for the final audit by competent authorities.
• Detailed audit report (non-conformities and recommendations).
• Support in managing non-conformities.