However, this turns out to be an odyssey through the depths of paperwork and various disconnected systems. Not all product and design changes made their way through the organization, making it hard to track them down to ensure compliance with complex regulatory requirements. Not only do you risk regulatory violations, you might be neglecting quality assurance and ensuring the safety of your medical devices. Simply put, the entire scenario could cost you not only hours of your precious time, but also hard money. In short, it’s a nightmare you would rather avoid.
I’ve heard firsthand from medical device manufacturers that this type of scenario is a cause of major concern.
The FDA Case For Quality and European Medical Device Directive were launched to provide medical device manufactures with guidelines for making sure medical devices meet high quality standards and guarantee patient safety. Now the question is: Are you prepared? Do you get headache thinking about implementing design controls, process controls and a quality system? You’re not alone when thinking about where to start.
The first step, as McKinsey suggests, is to shift from a document-centric to a product-centric approach. Don’t keep investing resources in your document management while neglecting other quality-related challenges across the product lifecycle. The key to success is to keep in mind the big picture and close the loop between all relevant data sources for full traceability.
To get started, download the Tech-Clarity Software Selection Guide for Medical Device Manufacturers. In it, you’ll find valuable advice and an overview of what you should take into account when choosing a software partner for your PLM journey.
The leading medical device manufacturer Medtronic already made an excellent choice and successfully implemented a PLM solution. Watch this short video to see how it gained real-time visibility into quality and performance across the lifecycle, from engineering through requirements validation, manufacturing, post-market surveillance and service.
If you’re wondering how to put the Case for Quality into effect, watch this on-demand webinar featuring European-based hearing aid manufacturer Microson explaining how it is dealing with these challenges.
Whether you are just starting or in the midst of your PLM journey, feel free to reach out to a PTC Medical Device Expert.