Opening doors to global markets by paving your pathway of compliance
We expertly steer your medical device journey through CE Marking, QMS implementation, FDA submissions, and rigorous auditing
Compliance Focus
Mastering complex regulatory landscapes with ease.
Assured Quality
Upholding the highest standards in the medical device industry .
Strategic Insight
Providing expert guidance for market success.
Navigating Medical Device Regulations with Confidence
Embark on a journey through the intricate world of medical device regulations with our expert team. We specialize in guiding you through the complexities of CE Marking, establishing robust Quality Management Systems, navigating FDA submissions, and conducting detailed audits of your internall processes and suppliers. Our tailored approach ensures that your products not only meet but exceed global regulatory standards.
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CE marking
Ensuring your medical devices meet all the safety and performance requirements of the EU's Medical Device Regulation (MDR 2017/745) for market access.
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QMS Support
Implementing and maintaining a robust Quality Management System compliant with standards like ISO 13485 and 21 CFR 820.
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Regulatory Submissions
Expert navigation of complex submission processes for Notified Bodies and FDA approvals, including 510(k), De Novo requests, and Q-Submissions
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Auditing
Conducting comprehensive internal and external audits to ensure continuous compliance with regulatory standards and quality assurance.
Internal audits
Supplier audits
Certification audits
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AI Regulation Consultancy
As pioneers in AI technology regulation for medical devices and software, we offer expert guidance in complying with ISO/IEC 42001, the EU AI Act, ISO 13485, and MDR 2017/745. Our consultancy ensures your AI innovations meet the highest standards of both AI-specific and medical device regulations, facilitating successful market access and regulatory adherence.
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Person Responsible for Regulatory Compliance - PRRC
Facilitating compliance and strategic oversight in medical device regulation by fulfilling the essential role of the Person Responsible for Regulatory Compliance (PRRC), ensuring adherence to all relevant regulatory requirements.
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Importation activities
Ensuring seamless EU market entry for medical devices with comprehensive importation services, focusing on compliance, documentation verification, and supply chain traceability under EU MDR 2017/745.
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Risk Management
Employing a systematic approach to risk management, we identify, evaluate, and mitigate risks in compliance with ISO 14971 and EU MDR 2017/745, ensuring your medical devices are safe and effective. Our proactive strategies and continuous monitoring enhance device reliability and uphold the highest standards of patient safety throughout the product lifecycle.
Consultancy Solutions for Every Stage of Innovation.
Stage 1 —
Understanding Regulations
Navigating the Basics
Every great healthcare innovation starts with a vision. Perhaps you're planning to introduce a new medical device or a digital health solution. Begin your journey by understanding the fundamental regulatory landscape that shapes the healthcare industry.
Stage 2 —
Early Development
Building Your Foundation
As you start developing your healthcare innovation, you'll encounter more specific regulatory requirements. This stage focuses on aligning your early-stage product development with regulatory standards to ensure a smooth transition to the next phase.
Stage 3 —
Compliance Stage
Establishing Regulatory Compliance
Moving beyond the basics, this stage delves into the intricacies of building your technical file and designing your regulatory submission. This involves the development a risk management file, clinical data, biological safety assessment and clinical evaluation.
Stage 4 —
Post-Market Surveillance
Ensuring Continued Safety and Efficacy
This crucial phase focuses on the continuous monitoring of healthcare products after market entry. It involves vigilant surveillance to track product performance, manage any risks, and respond promptly to any adverse events or feedback. This stage is essential for maintaining the highest standards of patient safety and product efficacy over time
