Balanced Quality Systems and Regulatory Compliance
Medical Device Quality and Regulatory Systems
See Product Risk page for information on new edition of IEC 62366-Usability
Bilanx Consulting LLC provides a balanced approach to development of quality systems, including product risk management, and regulatory compliance in the complex medical device regulatory environment.
The Medical Device Industry is becoming a more complex regulatory environment. In the US FDA Quality System regulations are stable, but new regulations are being implemented throughout the world. Revised and new international standards such as the Third Edition of IEC 60601-1, the electrical safety standard from medical devices are impacting the design of new devices. Activities of the Global Harmonization Task Force are improving the regulatory climate for manufacturers by working to develop common regulations.
