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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.
CE Marking
Secure your medical device's entry into the European market with our comprehensive CE Marking services. As a leading consultancy, we specialize in navigating the complexities of the EU's Medical Device Regulation (MDR 2017/745), providing manufacturers with the expertise needed to ensure safety and performance standards are met. Our process begins with a detailed conformity assessment, where we evaluate your device against specific requirements, followed by meticulous documentation preparation, including Clinical Evaluations and Risk Analysis. We also offer guidance through the Notified Body review process, addressing any queries and ensuring a smooth path to market access. With our knowledge of the latest regulatory trends and changes, we position your products for success in the competitive European healthcare sector.
Quality Management System Support
Strengthen your commitment to quality with our QMS Support services, tailored to the medical device industry's unique needs. We specialize in implementing and maintaining Quality Management Systems compliant with international standards like ISO 13485 and the FDA's 21 CFR 820. Our approach includes a thorough analysis of your existing processes, identification of areas for improvement, and integration of effective quality controls. By focusing on risk management, document control, and continuous improvement, we help manufacturers establish a QMS that enhances product quality, ensures regulatory compliance, and fosters operational efficiency. Our expert guidance is designed to simplify the complex landscape of quality assurance and regulatory compliance, making it easier for medical device manufacturers to focus on innovation and growth.
Regulatory Submissions
Navigate the regulatory maze with ease with our Regulatory Submissions services. We offer expert navigation of complex submission processes for Notified Bodies and FDA approvals, including 510(k) submissions, De Novo requests, and Q-Submissions. Our team stays updated on the latest FDA guidance and international regulatory trends, ensuring that your submissions are strategic, well-prepared, and compliant. We provide comprehensive support, from pre-submission strategy and document preparation to submission management and post-submission follow-up. Our goal is to streamline the approval process, reduce the time to market, and help manufacturers understand and meet regulatory requirements effectively.
Auditing
Maintain the highest standards of quality and compliance with our in-depth Auditing services. We offer a range of auditing solutions, including comprehensive internal audits, supplier audits, and certification audits, tailored to the medical device industry's unique needs. Our experienced auditors employ a systematic approach to evaluate your processes against regulatory standards and identify areas for improvement. By providing actionable insights and recommendations, we help manufacturers enhance their quality systems, ensure continuous compliance, and prepare for regulatory inspections. Our auditing services are designed to provide peace of mind and support manufacturers in their commitment to delivering safe and effective medical devices.
Person Responsible for Regulatory Compliance - PRRC
Ensure strategic oversight and continuous regulatory adherence with our dedicated PRRC services. The Person Responsible for Regulatory Compliance plays a crucial role in maintaining the compliance of medical devices under the EU MDR and IVDR. We provide expert services to fulfill this role, offering strategic guidance, oversight of QMS establishment and maintenance, and acting as a communication link between manufacturers and regulatory authorities. Our PRRC services are designed to ensure that all regulatory obligations are met, providing manufacturers with the assurance that their products remain compliant and competitive in the European market.
Importation Activities
Facilitate the smooth entry of your medical devices into the EU market with our specialized Importation Activities services. Navigating the complexities of EU MDR 2017/745, we ensure that every aspect of the importation process is managed efficiently and complies with all regulatory requirements. Our services include verifying documentation, maintaining supply chain traceability, and ensuring that your medical devices meet all the necessary safety, performance, and labeling standards. By handling the intricate details of the importation process, we help manufacturers focus on their core business while ensuring their products successfully reach the European market.
Risk Management
Protect your patients and your reputation with our comprehensive Risk Management services. Following ISO 14971 principles, we assist manufacturers in identifying, evaluating, and controlling risks associated with medical devices throughout their lifecycle. Our approach includes conducting thorough risk analyses, implementing effective risk control measures, and continuously monitoring for new risks. By integrating risk management into every stage of the product development and post-market process, we help manufacturers not only comply with regulatory requirements but also enhance the overall safety and performance of their medical devices.
Artificial Intelligence (AI) Regulation Consultancy
As one of the first regulators tackling the new frontier of AI technology in medical devices and software, our AI Regulation Consultancy stands at the forefront of this rapidly evolving domain. Our expertise lies in ensuring compliance with advanced standards like ISO/IEC 42001 for AI management systems and the EU AI Act, while we also keep abreast of regulatory changes in key global markets such as the US, UK, and China.
Our approach integrates these AI-centric regulations with the established frameworks of ISO 13485 and the Medical Device Regulation (MDR 2017/745). By partnering with us, you are aligning with a visionary leader in AI regulation, ensuring that your AI innovations are not only technologically advanced but also in full compliance with the latest and most stringent AI-specific and medical device regulations, setting a benchmark for successful market access and regulatory adherence.
ISO/IEC 42001 Compliance: Our consultancy provides in-depth expertise in aligning your AI systems with ISO/IEC 42001 standards, focusing on AI management systems. This includes guidance on ethical AI use, risk management, and ensuring that AI decision-making processes are transparent, reliable, and accountable.
EU AI Act Navigation: We offer comprehensive services to ensure your AI applications comply with the EU AI Act, focusing on high-risk AI systems. Our team helps you navigate through the Act’s requirements, from data governance to algorithmic transparency, ensuring your products meet EU standards.
Integration with ISO 13485 and MDR 2017/745: We excel in harmonizing AI-specific regulations with existing medical device frameworks. Our consultancy ensures that your AI-enhanced medical devices are not only innovative but also adhere to the quality management systems stipulated in ISO 13485 and comply with the Medical Device Regulation (MDR 2017/745). This holistic approach guarantees product safety, efficacy, and quality.
Tailormade Regulatory Strategy: Recognizing that each AI application is unique, we offer tailored strategies to address specific regulatory challenges. Whether it's navigating the approval process, conducting risk assessments, or implementing post-market surveillance strategies, our consultancy provides end-to-end support.
Market Access and Compliance Assurance: By partnering with us, you gain an ally who not only understands the intricacies of AI in medical devices but also remains at the cutting edge of regulatory developments. We ensure your products not only meet current regulations but are also prepared for future changes, paving the way for smooth market entry and sustained compliance.
Our consultancy is more than just a service; it's a partnership that positions your AI innovations at the forefront of medical technology, ensuring they are safe, effective, and ready to make a transformative impact in healthcare.