Science Firmware Electrical Mechanical Design Integration Medical

ISO 9001:2008 & ISO 13485:2003 Certified

Medical Device Development

Key Tech understands the extra challenges you face manufacturing medical devices. Patient safety is your priority, so we design and strictly test to appropriate Safety Protocols, such as IEC60601. To help your FDA submission go quickly and smoothly, we control our files, track revisions, provide the complete Design History File, and support your clinical trials.

Let our experienced engineers, scientists, and designers help you bring your next medical device to market.

ISO13485, ISO9001 Certified

Document Control

Pre-production Prototyping

Design History File

Regulatory Compliance

Clinical Trials Support