Trusted Technology Development Solutions for Medical Devices
Integral Medical Device Consulting’s consultants boast extensive expertise in clinical, electrical, mechanical, and chemical engineering. With in-depth knowledge of standard industry design practices, we ensure your team stays focused on true innovation instead of reinventing the wheel.
Compliant Product Development Processes
Under ISO-13485 and 21 CFR Part 820.30, medical devices must undergo a multiphase development process with appropriate phase gates and checks and balances.
Our team will help you establish a compliant Design Control Process, leading to a Device History File (DHF) ready for regulatory submissions.
Reliability Engineering for Medical Devices
In today's competitive market, acquiring companies demand safe and reliable medical devices. We will help you develop a robust reliability program that drives design improvements and showcases the overall value of your disruptive technology.
How Can We Help You?
Get efficient solutions for your business’s needs at Integral Medical Device Consulting. Connect with us to schedule an appointment or learn more about our services.