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. FDA has stepped up enforcement actions over doubling Warning Letters, prepare before the investigators arrive.
The Medical Device Industry is becoming a more complex regulatory environment. In the US, FDA Quality System regulations are stable, but enforcement has changed. 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. While in the past, the activities of the Global Harmonization Task Force were improving the regulatory climate for manufacturers by working to develop common regulations, the organization has been disbanded and replaced with a new organization by the regulators. The industry is monitoring this change.
