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China’s Food and Drug Administration plans to revise more than 300 standards by 2020, according to a new two-year plan for bringing the country’s medical devices and in vitro diagnostics up to international standards. Read More
Boston Scientific is facing regulatory hurdles with its proposed manufacturing process and design changes to bring its transcatheter aortic valve back to the U.S. and EU markets. Read More
Health Canada is sticking to its compliance deadline of Jan. 1, 2019, for devicemakers selling products in Canada to transition to the Medical Device Single Audit Program, but is making adjustments to help small to medium-sized enterprises comply. Read More
The FDA inspector said the firm failed to establish a design history file to demonstrate that the design was developed to comply with 21 CFR Part 820. Read More
The system was designed to solve the problems experienced with the use of stiff metal screws that restrict normal joint motion and with flexible fixation… Read More