Services
Medical Device Risk Management (ISO 14971)
Comprehensive Risk Management for Medical Devices
We specialize in robust risk management assessments and strategic development tailored for the medical device industry. Our approach aligns with ISO 14971 standards, integrating risk-based decision-making to proactively address risks throughout the device development lifecycle and beyond. By employing comprehensive methodologies, we ensure your devices are safe, effective, and compliant with global regulations.
Medical Device Usability (IEC 62366-1)
Enhancing Medical Device Usability and Safety
We offer expert usability engineering services, integrating IEC 62366-1 principles and FDA human factors guidelines to enhance the safety and effectiveness of medical devices. Our proactive approach addresses user needs and potential use errors from the design phase, ensuring a user interface that complies with regulatory standards and is optimized for practical use. We conduct comprehensive human factors validation tests to uncover and mitigate use-related risks, ensuring the device operates safely and effectively under real-world conditions.
Regulatory Compliance Consulting
Comprehensive Regulatory Documentation and Compliance Services
Providing specialized guidance tailored to medical device development and lifecycle management teams. Our services include thorough gap analyses to address discrepancies and ensure compliance with regional requirements. We prepare comprehensive design documentation for FDA 510(k) submissions and create technical files that align with the EU MDR. Our personalized approach empowers teams to navigate regulatory landscapes, facilitating market access and maintaining high product standards. With our strategic guidance, your team can refine documentation processes and sustain compliance confidently.
Global Medical Device Standards and Compliance
Navigating Global Compliance for Medical Devices
Our consultancy is dedicated to providing comprehensive compliance solutions for medical device companies, steering you expertly through the complexities of international safety standards and conformity assessments. We conduct in-depth gap analyses to pinpoint and rectify any discrepancies in current processes that may arise from standards revisions. Our services encompass support for critical safety standards like IEC 60601-1 and IEC 60601-1-2, as well as broader industry standards, ensuring that your products not only meet requirements for electrical safety and electromagnetic compatibility but also align with the latest in standardization. With our actionable recommendations, we set the course for your products to achieve global market access, enhanced compliance, and continuous improvement in a constantly advancing regulatory environment.