MET will review information about the current status of medical product safety regulatory requirements. This is a complimentary broad overview that will mostly cover the United States, Canada and Europe.
Topics will include:
I. What editions are currently accepted in the U.S., including a discussion about FDA vs. OSHA (workplace acceptance)
II. What editions are accepted in Canada.
III. What editions are accepted in Europe.
IV. Discussion about the 3rd edition to include:
a. Overview of significant differences as compared to previous editions
b. Review of risk management and the manufacturer’s responsibility
c. Mandated use of collaterals
d. Part 2 standards
MET has been certifying, listing, and labeling products for electrical product safety for more than 40 years. In that time, MET has certified thousands of products for compliance to electrical safety standards. This translates into millions of products sold in the U.S. and Canada labeled with the MET Mark.
MET Laboratories certifies or tests medical electrical equipment for:
• Product safety compliance in the United States and Canada
• EMC compliance
• FDA Guidance Documents and consensus standards necessary for
FDA clearance, including IEC 60601, AAMI and ASTM standards.