By Ken Herold
Every medical device manufacturer marketing their device in the US must comply with regulations such as 21 CFR 820.50 Subpart E Purchasing Controls. This applies to all outside components they wish to incorporate into their device, including software. In part, this requires the manufacturer to:
“(1) Evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements. The evaluation shall be documented.”
In a practical sense, this means that if they want to build on top of third-party software such as an operating system, they will need to provide their quality or purchasing department information about the development environment of that software. The goal is to be sure that the software is appropriate for the intended use of the medical device itself. The amount of scrutiny a particular component (software or otherwise) is given is determined by the effect its failure would have on the patient using it. A medical device manufacturer may have an in-house questionnaire that they fill out for all of their suppliers. These are often not geared toward software and can be lacking, putting extra pressure on the (poor) engineer that is charged with proving the quality of the software they are about to incorporate into their life-saving device. Without a stamp of approval from the purchasing department, that software isn’t going into any product. A software vendor experienced in the healthcare market will have prepared documentation with this task in mind.
Enter the Vendor Quality Summary (VQS), a key component of the Wind River Platform for Medical Devices. This document provides the necessary information about Wind River the company, the product development philosophy and support organization as mandated by the FDA under Purchasing Controls. This eases the burden on sourcing and engineering organizations to qualify their OTS supplier of choice and add them to the preferred vendor list. More than that, it gives everyone involved confidence that when they move to the next step in process, that Wind River will have the answers at hand. This means that when a specific product is put into a specific medical device, that the requirements in the Off-The-Shelf Software Use in Medical Devices Guidance can be satisfied and the engineers can focus on their technology, not the regulatory process.
Is this then end of the effort for engineering? Certainly not! Mitigating risks associated with any medical device is an ongoing effort that starts at software development planning and extends past product release to the maintenance phase. For those devices where the hazard analysis shows software is a major level of concern, additional information and an audit of the supplier may be necessary. Device manufacturers are looking for a vendor that wants to be a partner, is forward thinking enough to have this information already compiled and is ready for an onsite audit.
As a medical device manufacturer, prepare yourself for this requirement by interviewing your software vendors. Contact your vendor’s sales representative – who knows, they may even teach you a thing or two! Wind River software has been used in approved medical devices of all classes and will gladly provide you with the information and artifacts you need to get your device approved quickly and efficiently.
Link to FDA regulations: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1