Success in the medical device sector depends not just on a great product. It depends on the rigour of your processes, good operational governance, and rock solid design controls. Our platform for a Cloud-based Quality Management System helps you get there.
Many eQMSs are clunky and prescriptive. But in order for medical device development to succeed, your quality management system should be scaled to the size, complexities and requirements of your company. No more, no less. Only then, you can focus on product safety and getting to market quicker. This is exactly what Cognidox allows you to do.
Our engineers created a cloud-based QMS platform built on a document management system with a lean approach to design controls and quality compliance. We allow you to continue to use your existing procedures and documentation but, on a complaint, electronic platform. Then we add all the extras to take your quality management system to the next level. This way, you build your eQMS to suit you.
Question for you: is the product you intend to develop a Medical Device, an In Vitro Diagnostic Medical Device (IVD), or Software as a Medical Device (SaMD)? These distinctions are important because they’re going to impact the lead time and the rigour of the certification processes you’ll have to ...
A QMS should ultimately help guard against customer harm or dissatisfaction, by guarding against the risk of failure of the design and build processes. In turn, this helps avoid the commercial failure of the product itself, too. But how do you achieve this? In this article, you’ll read about medic...
Developers who want to release a medical device in the US need to seek permission from the FDA. Depending on the classification of your device, this can mean obtaining 510(k) clearance by submitting a package of documentation complete with a cover letter for the FDA to approve. But what can go wro...