Regulatory compliance

Regulatory compliance - Regulation (EU) 2017/745 and FDA

Ensure the compliance of your medical devices with Med'In QARA

Navigating the complex world of regulatory requirements may seem like a challenge, whether it's Regulation (EU) 2017/745 in Europe or the FDA in the USA, but meeting these requirements is a crucial and essential step in bringing a medical device to market.

With Med'In QARA, I'll support you at every stage of compliance, bringing you my expertise to secure access to markets.

Regulation (EU) 2017/745: a rigorous regulatory framework

Regulation (EU) 2017/745 imposes strict requirements on manufacturers, including compliance with the General Safety and Performance Requirements (GSPRs), defined in Annex I, when designing devices, the preparation of Technical Documentation in accordance with Annex II, and the implementation of Post-Marketing Surveillance (PMS and PMCF) in accordance with Annex III, in order to guarantee the safety and efficacy of medical devices.

The approach begins with the precise definition and destination of your device and its classification, which will enable us to draw up the corresponding regulatory strategy. Together, we build a robust compliance plan, including the necessary documentation (Technical Documentation, Declaration of Conformity, etc.) and the implementation of a Quality Management System (QMS) compliant with ISO 13485 and Article 10 of Regulation (EU) 2017/745 (for the European market) or QSR 21 CFR Part 820 (for the US market).

Contact Med'In QARA

My support for full compliance with
Regulation (EU) 2017/745

Regulatory compliance strategy

Technical Documentation (TD)

Post-Marketing Surveillance (PMS)

FDA compliance: prepare to enter the U.S. market

Access to the US market requires an understanding of FDA regulatory requirements, notably the QSR (Quality System Regulation) 21 CFR Part 820 and the various marketing authorization procedures such as 510(k) or PMA (Premarket Approval).

I'll help you structure your file to ensure that your medical device meets U.S.-recognized quality and safety standards. My support includes:

Development of your QMS according to QSR: QSR, which is similar to ISO 13485, imposes strict requirements in terms of process control and quality management. I support you in aligning your QMS with the requirements of 21 CFR Part 820 (and related parts), ensuring that all your critical processes are documented, controlled and compliant.
510(k), PMA or De Novo submission: Depending on the classification of your device, a 510(k) submission, PMA clearance or De Novo procedure may be required. I'll guide you through the process, ensuring that each section complies with FDA expectations, including evidence of safety and efficacy.

Benefits of my regulatory compliance support

With Med'In QARA, you benefit from personalized support that simplifies the compliance of your regulatory dossiers and reduces time-to-market. By complying with the requirements of Regulation (EU) 2017/745 and the FDA, you secure your access to European and US markets, boosting the confidence of your customers and partners.