Consultants at Integral have a wealth of experience in clinical, electrical, mechanical and chemical engineering. With direct first hand knowledge of standard industry design practices, we can help your team stay focused on true innovation as opposed to reinventing the wheel.
Product Development Processes
ISO-13485 and 21 CRF Part 820.30 require medical devices to be developed in accordance with a multi-phase process with appropriate phase gates with checks and balances. Integral Medical Device Consulting will help your team establish a compliant Design Control Process that yields a DHF that is ready for regulatory submissions.
Today’s acquiring medical device companies do not tolerate fundamentally unsafe or unreliable products. Integral consultants can help develop a reliability program will drive design improvements and allow you to showcase the full value of your disruptive technology.