Navigating Medical Device Design Control & Risk Management
Helping you navigate integrated design control and risk management, while providing complete visibility into the entire development process for your medical device.
Let’s take a look at GAMP® 5. GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems is an industry standard for automated manufacturing developed and published by the International Society for Pharmaceutical Engineering (ISPE). Its description states: “GAMP® 5 provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner.” In short, it suggests a framework for a risk-based approach to validation on a computerized system.
The AAMI Technical Information Report (AAMI TIR36:2007) is a standard that covers the validation of software for regulated processes. TIR36 focuses on the machines, software, and processes involved with manufacturing devices and other products. Medical device engineer David A. Vogel lays out strategies for medical device companies in their automated process software validations, and includes a bit of history of multiple standards like TIR36, in Medical Device Software Verification, Validation and Compliance.
Subscribe to the blog and get this guide for free
“It typically takes 20 to 40 years or more for scientific discoveries to trickle down to benefit human lives in a meaningful way… This is unacceptable.” - Sandra Bond Chapman, founder and director of the Center for BrainHealth at the University of Texas The medical device industry has always complained about the speed at which FDA operates. Companies are concerned about the time it takes for approvals due to compliance—they want fast commercialization. This is especially frustrating when comparing to follow on pharmaceuticals.
Working in the product development world is new to me, especially the medical sector. Much of the jargon is complex and difficult to remember. For example, it took me quite a while to finally nail down the difference between verification and validation. They have similar definitions, but are very different. Here’s the simple breakdown: Verification is making sure you have been making the product correctly to the requirements you defined, it has the right parts, and it is assembled the correct way. Think of it as an internal review of all the inputs, bits, and pieces used to make a finished item. Look at this image for illustration. It starts at user needs and flows down to a finished device.