What do you do when regulatory requirements exceed reasonable engineering controls? – Part 1

What do you do when regulatory requirements exceed reasonable engineering controls? This is the first part in a six-part series that will answer that question through real-life case studies from MED Institute, a company that performs nonclinical medical device testing.

Before we answer the question of what to do when regulatory requirements exceed reasonable engineering controls, we’ll answer the question of why regulatory requirements might exceed reasonable engineering controls.regulatory requirements image There are often not standardized or publicized engineering or regulatory requirements. Regulatory requirements might differ from engineering controls because the company may have more knowledge and clinical experience about their devices than the regulatory body. Or they might differ because advances in knowledge and technology have outpaced the drafting of regulations.

When a discrepancy exists between regulatory requirements and your own engineering controls, you have several possible courses of action:

• Accept the regulatory body’s requirements.
• Convince the regulatory body that your controls are adequate.
• Negotiate a new agreement prior to development or after model and test development.

Each of these choices has advantages and disadvantages. In the next part of this series, we’ll look at the first of five real-world case studies in which MED Institute faced these kinds of discrepancies.

For more information about us, please visit our website at http://www.medinstitute.com

MED Institute doesn’t just meet standards—it sets them.


MED Institute not only adheres to medical-device testing standards but also helps to set them, working with organizations such as the American Society for Testing and Materials (ASTM) to develop standards for medical and surgical materials and devices.

I’m Brian Choules, the director of nonclinical testing at MED Institute, and I serve on several standards committees; I’m also the chair for ASTM’s F04.30 cardiovascular standards committee. I get great enjoyment out of putting our practices into standards.

I’ve been extensively involved in writing test methods and contributing to standards since 2000 for ASTM as well as for the Association for the Advancement of Medical Instrumentation (AAMI), the American Society of Mechanical Engineers (ASME), and the International Organization for Standardization (ISO).

MED Institute’s involvement in setting standards benefits researchers and the industry—and it also benefits MED Institute. By helping to set these standards you get to lead and mold practices, but you also learn from others, so you keep up to date with the most advanced test methods.

Standardization is about coming to a consensus on the best way to do things. Sometimes fields are very new and no one really knows the best way to do things, so these standards are invaluable in setting a direction.