Items Tagged with 'FDA regulations'

Picking the right adhesive almost always entails a balancing act as engineers attempt to find products that meet conflicting end-use and manufacturability requirements. Medical device engineers, who also have to contend with a strict regulatory environment, often have the toughest time striking that balance.

Designing a new medical device is a bit more complicated than designing a toaster or an automotive cooling system. Besides the issues common to any product—feasibility, usability, and design for manufacture and assembly—there are also issues of biocompatibility, sterilization and FDA regulations to deal with.

STAFFORD, TX—The FDA issued a warning to CooperSurgical after inspectors noted violations at the company’s assembly plant here.

WASHINGTON—The FDA is planning to develop a new unique device identification system to track high-risk medical devices.

More than 90 percent of electronic medical devices initially fail to comply with standards.