We are foremost experts in medical devices including surgical instruments, physiological monitors, radiation therapy, robotic surgical platforms, imaging, endoscopes, catheters, and active implants and their technologies. We have expertise in all the applicable international standards including safety, IEC 60601/ISO 80601 series; risk, ISO 14971; EMC, IEC 60601-1-2, IEC TR 60601-4-2; software, IEC 62304; and usability, IEC 62366.
Helping our clients through compliance issues from design to implementation
Verifying your design to applicable standards so that your product is safe to market
Explaining the complexities of integrating medical device safety into your design process, equipping your team with the tools they need to move forward
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