Medical Device Ventures Built Right

Serving the U.S. and Europe for Over 25 Years

Medical Device Ventures Built Right

Serving the U.S. and Europe for Over 25 Years

Proven Solutions for Success in the Medical Industry

Developing innovative medical therapies is a complex process that requires a coordinated team effort and a disciplined approach.

At Integral Medical Device Consulting, we ensure your company has the systems to achieve your goals with an accelerated schedule. Our advisors will help you navigate the challenges of the medical device industry.

Our Value-Driven Services

We understand that acquiring companies employ regimented due diligence processes to identify risks in quality, operations, product design, and other critical business practices. Gaps in these areas can negatively impact valuation as acquirers consider the cost and time for remediation.

Our consultants leverage their broad experience to develop custom solutions that address weaknesses and align resources for a robust implementation.

New Project-733

Our quality management systems services focus on ISO-13485 and FDA Compliance and Remediation, helping your company maintain the highest quality standards.

Our technology developers are well-versed in engineering, reliability engineering, and design control, ensuring your medical devices meet industry standards.

We help you achieve operational excellence through internal/contract manufacturing, EH&S, order-to-cash, and cost accounting services.

Our advisors prepare your company for success through strategic consulting covering due diligence, senior leadership, and corporate culture.

See What Clients Say About Us

James McLaren
Managing Director - TM Asante Healthcare Partners

As part of the Sapheon management team, Bruce Choi developed operations and management systems consistent with industry best practices and excelled during due diligence. Bruce’s experience and leadership would be an invaluable asset to any Medical Device start-up.

Vice President of Sales - Medical Device Start-Up Company

Our company’s transition from a development company to a commercial one was seamless, thanks to the Supply Chain Bruce developed. Our sales team was able to focus on making sales without worrying about product quality or availability.