Article 16 of the European Union’s Medical Device Regulation and In Vitro Diagnostic Regulation specifically address the ...

In the medical device industry, FDA inspections are not a regulatory hurdle — they are a powerful tool for improving product quality, operational efficiency, and patient safety. Shift from a reactive ...

A virtual start-up identified a significant opportunity to develop a catheter-based embolic protection device for high-risk patients undergoing transcatheter aortic valve replacement (TAVR). Lacking ...

Handling and assembling or packaging micro-sized medical devices is far more challenging, and the solutions are different than those employed in making macro-sized parts. MTD is FDA registered and all ...

E01 fast-cure epoxy is for rapid repair on maintenance items such as metals, plastics, glass and other porous ceramics. E01 fast-cure epoxy is for rapid repair on maintenance items such as metals, ...

As medical device OEMs have narrowed their strategic focus to core competencies, innovation, and global market expansion, demand has grown for CMO partners with proven capability to operate in a ...

SMC provides manufacturing and assembly services for full devices or subassemblies for finished devices. Our global facilities offer ISO 13485 systems for assembly as well as kitting and packaging ...

Plastic luer fittings are widely used in medical devices and other applications for secure fluid transfer connections. However, with the availability of different types and models of luer fittings in ...