Med'In QARA - Regulatory compliance
Regulatory Compliance - MDR 2017/745 and FDA
Ensure the compliance of your medical devices with Med'In QARA
Navigating the complex world of regulatory requirements can seem like a challenge, and complying with regulatory requirements, whether MDR 2017/745 in Europe or FDA in the US, is a crucial step in bringing a medical device to market.
With Med'In QARA, I can support you at every stage of your compliance process, providing you with tailor-made expertise for secure access to markets.
MDR 2017/745: a rigorous regulatory framework
MDR 2017/745 imposes strict requirements on manufacturers, including compliance with General Safety and Performance Requirements(GSPRs) during device design, preparation of Technical Documentation, and Post-Market Surveillance(SAC and SCAC), in order to guarantee the safety and efficacy of medical devices.
The approach begins with an assessment of your product's specific needs and classification, followed by the development of a precise regulatory strategy. Together, we build a robust compliance plan, including the necessary documentation (Technical File, Declaration of Conformity, etc.) and the implementation of a Quality Management System (QMS) compliant with ISO 13485 and Article 10 of European Regulation 2017/745 (for the European market) or QSR 21 CFR (for the US market).
My support for full MDR compliance:
Regulatory compliance strategy
Technical Documentation (TD) and Risk Management File (RMF)
Post-Marketing Surveillance (PMS)
FDA compliance: preparing your devices for the US market
Access to the US market requires an understanding of FDA regulatory requirements, including QSR(Quality System Regulation, 21 CFR Part 820) and 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:
- Developing your QMS according to QSR: QSR, which is similar to ISO 13485 with a few special features, 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 medical devices and reduces the time it takes to obtain authorizations. By complying with the requirements of MDR 2017/745 and the FDA, you secure your access to European and American markets, boosting the confidence of your customers and partners.
Clinical approach according to MDR 2017/745
Optimize your clinical approach to MDR compliance
To demonstrate the safety and performance of medical devices on the European market, a thorough clinical evaluation is required.
In order to guarantee the excellence of this service, I have established a contractual partnership with a reconverted Doctor specializing in regulatory clinical support (22 years' experience in the sector), and with a highly qualified multidisciplinary team made up of Doctors, Pharmacists, Clinical Research Associates and Biostatisticians. Together, we support you in meeting the clinical requirements of MDR 2017/745, while ensuring smooth coordination and total transparency.
Our integrated clinical approach
The clinical approach we propose is designed to fit in with your regulatory strategy, and articulate with your design files, risk management and Technical Documentation. We work closely with your team (Clinical Affairs department, Medical Reviewer...) to organize, structure and document all the clinical evidence for your device.
Benefits of Med'In QARA's clinical approach :
Drafting and planning the Clinical Evaluation Plan (CEP)
Research and review of scientific literature
Clinical Development Plan and Clinical Evaluation Report (CER)
Support for clinical investigations
Documentary reconciliation
Summary of safety and clinical performance characteristics (SSCP)
Post-market clinical follow-up (SCAC)
Why entrust your clinical approach to our team?
By outsourcing clinical assessment to a specialist team, you have access to dedicated, cutting-edge expertise. This approach ensures that all the requirements of MDR 2017/745 are met, while enabling more flexible and responsive management. With us, you benefit from structured, coordinated and efficient support, which reduces your clinical compliance times and secures your operations on the European market.
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