Services
Regulatory Compliance Consulting
Comprehensive Regulatory Documentation and Compliance Services
At Medestan Consulting, we specialize in preparing FDA 510(k) submissions and EU MDR technical files, ensuring your medical device meets regulatory expectations for market approval. Our expertise in documentation, risk management, and standards compliance helps streamline the submission process, reducing delays and regulatory hurdles.
To support successful FDA 510(k) and EU MDR submissions, we conduct comprehensive gap analyses to identify potential compliance risks and ensure regulatory alignment. Our personalized approach helps your team navigate regulatory strategy, technical documentation, and risk-based decision-making, ensuring a clear and efficient path to market approval.
With our expert guidance, you can accelerate market access, ensure compliance, and confidently bring your medical devices to market.
Global Medical Device Standards and Compliance
Ensuring Compliance with International Standards
Our consultancy is dedicated to providing comprehensive compliance solutions for medical device companies, expertly guiding you through the complexities of international safety standards and conformity assessments. We thoroughly assess compliance status to identify and address any discrepancies in current processes that may arise from standards revisions.
Our services support compliance with key international standards, including IEC 60601-1 and IEC 60601-1-2, ensuring that your products align with evolving regulatory requirements. We provide actionable recommendations to help manufacturers navigate conformity assessments, market entry requirements, and ongoing compliance needs. Our expertise ensures your products meet global safety and performance standards, supporting successful regulatory approvals and continuous improvement in a dynamic regulatory environment.
Medical Device Risk Management (ISO 14971)
Comprehensive Risk Management for Medical Devices
We specialize in implementing the ISO 14971 risk management process, ensuring your medical devices meet safety and regulatory requirements. With deep expertise in risk-based decision-making, we provide the necessary support to align with FDA and EU MDR expectations for regulatory submissions. Our approach ensures that risk management is fully integrated into the development process, documentation, and compliance strategy.
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.