Do you know why some processes are more “Special” than others? Process validation is an essential part of establishing a manufacturing process. Jean Boudaud takes a detailed look at what’s involved and demystifies all that IQ/PQ/OQ stuff.
Businesses wishing to market Class II Medical devices (or certain Class I and III) or IVDs in the USA are required to obtain premarket clearance through the 510(k) notification process.
When you’re considering the US market for your product, you may have spent hours browsing through the internet, reading through mountains of regulations, guidance documents and standards, researched published white papers and yet… you’ve not been able to answer one fundamental question, “Do you have the right 510(k) strategy?”
FDA has published a detailed draft guidance on regulation of 3D printed devices. Offering detailed advice on both design and manufacturing and on device testing, the guidance exposes the agencies “initial thinking” on regulatory controls for 3D printed devices. What is a “Leap Frog Guidance anyway? Read on…
Design controls are a crucial element of a medical device manufacturers quality management system.
Design controls cover the development of a device from concept to commercialisation.
Design controls apply to all changes to the device and the manufacturing process design, including your sub-contractors. But it does not stop there…
OK here’s a quick quiz: which is the only part of the FDA’s Quality System Regulations apply to a manufacturer before they have received 510(k) clearance? Pat on the back for all who answered “21CFR 830.30” – that’s the Design Control regulation, and FDA requires that manufacturers comply with this regulation during the product development […]