Introduction
At RQA Medical, our dedication to delivering transformative solutions extends from our executive team to our renowned thought leaders. Our extensive team of experts features former leaders from notified bodies, ex-regulators, and members of committees that draft guidance documents. Our executive team is distinctively qualified to drive business growth and guarantee client success.
RQA Medical International Ltd maintains strong industry connections with the FDA, various notified bodies, industry partners, laboratories and health organizations worldwide. These relationships establish us as a premier source of up-to-date insights and best practices.
Our Services
🔹 Regulatory Training and Workshops:
Equip your team with the knowledge and skills to navigate regulatory landscapes confidently.
Coaching and mentoring of QARA staff.
Supporting Senior Management with an appropriate strategic regulatory and compliance plan.
🔹 Technical Documentation Preparation:
Create comprehensive and compliant documentation to support your regulatory submissions.
🔹 Clinical Evaluation Reports (CER):
Compile robust clinical evidence to demonstrate the safety and performance of your device.
🔹 Quality System Implementation:
Develop and maintain a world-class QMS to streamline operations and ensure compliance.
🔹 Person Responsible for Regulatory Compliance (PRRC) Services:
Ensure your medical devices meet stringent regulatory standards with our expert Person Responsible for Regulatory Compliance (PRRC) services. Our seasoned PRRC professionals provide comprehensive guidance and support to ensure your products are compliant and market ready.
🔹 UK Responsible Person Services:
To place a medical device or IVD on the GB market, manufacturers outside the UK must appoint a UK Responsible Person (UKRP). Using RQA Medical’s experienced UKRP services, we can guide you through the regulatory compliance requirements for your devices, ensuring a smooth market entry.
🔹 Second and Third Party of Supplier Auditing Services:
Enhance your supply chain integrity with our comprehensive Second or Third-Party Supplier Auditing Services. Our expert auditors ensure your suppliers meet the highest standards of quality and compliance, safeguarding your product’s reliability and reputation.
Auditing in China : Second party auditing – supplier approval, supplier evaluation, supplier performance and compliance with contractual terms.
🔹 Regulatory Training and Workshops:
Equip your team with the knowledge and skills to navigate regulatory landscapes confidently.
🌍 Global Reach, Local Expertise:
Whether you’re entering new markets or maintaining compliance in existing ones, our global network of consultants ensures you have the local insights and international expertise you need.
🎯 Achieve Compliance, Ensure Quality, Drive Innovation:
At RQA Medical International, we understand that navigating regulatory requirements and maintaining quality standards can be challenging. That’s why we’re here to help you every step of the way, so you can focus on what you do best – innovating and delivering life-changing medical devices.
📞 Get in Touch:
Ready to elevate your regulatory and quality processes? Contact us today for a consultation and discover how we can help you achieve compliance and excellence.
Together, let’s shape the future of healthcare, breaking down barriers and challenges in bringing the right care and provision of medical devices to our communities, one compliant, high-quality, safe medical device at a time.