Specializing in Electrical Medical Devices
Risk Management based on ISO 14971
Usability based on IEC 62366 and IEC 60601-1-6
Requirements for Access to the European Union
Expert Witness for Electrical Medical Devices
We provide help with medical device conformity assessment, testing, risk management, and regulatory acceptance. Our mission is to provide this help as fast as possibe -- in order to help speed your product to the market where it can provide benefits to patients.
Fast information, straight answers, and clear guidance.
This is our promise to you when you invite us to
form an Active Alliance with you.
Test experts for the IEC 60601-1 series
Testing and documenting compliance to medical
and laboratory equipment standards
Class I and Class IIa/IIb medical devices
Webinars & Training, Clinical Documents, Pre-Compliance Design Review,
Coordination of Formal Certification with Agencies/Regulatory Bodies, and ISO 13485
Support to medical device companies for U.S., Canadian, European,
and other international regulations.
Preparing FDA 510(k)s, IEC 60601-1 series of standards, Quality Systems,
CE Mark, Canadian Medical Device Regulations (CMDR), and training.