Mediso Case Study: Consistency In A Changing Regulatory Environment
Cognition has been a trusted resource for the largest and most prominent medical device and pharmaceutical companies for more than 20 years and pioneered Cognition Cockpit, an intuitive, web-based application empowering the Product Development Process (PDP).
The company’s SaaS-based solutions – such as Compass – enable customers to structure their data and automate compliance proc
Here’s a short overview:
Mediso Medical Imaging Systems develops complex imaging systems for healthcare and medical research institutions worldwide including SPECT/CT/PET scanning and MRI systems.
These systems are part of a larger product family and, while each system is in itself a unique offering, common components are modular and interchangeable. Both the challenge and the opportunity with modular systems are to accurately, efficiently, and reliably share information and avoid repetitive work.
Mediso needed a faster, more accurate, and repeatable way to manage this product family information in a way that could also rapidly generate accurate compliance deliverables for Notified Body regulatory submissions.
This relied on providing the right information and getting the hardware and software out to the marketplace by passing first reviews.
Only need to test the new parts while configuring a new product from a ‘super project’
The future goal was to create a library set up for the Mediso product family – with the aim to reuse previous documentation and put it together quickly and easily into a new product and create variants for similar and new devices: and only test the new parts whereas most of the product is configured from a ‘super project’. Untouched parts can reuse existing test results from the ‘super project’ – unless explicitly decided or required to re-test as well.
The challenge is familiar to many organisations working in a highly regulated environment such as medical devices. A common goal is to deliver new submittable information without having to re-do all your work all over again. Traditionally in medical testing protocols, for a new product albeit just a variant you typically have to deliver a 100% whole new set of tests, even if only 10% is new work.
Tests become a laborious and inefficient use of time. The solution provided by Cognition allows the management and production teams at Mediso to essentially ‘zoom in or zoom out’ and still have a consistent picture of all interactions, information and flow process through the approach to systems engineering.
Immensely powerful tool for future proofing processes and products
Another challenge met by medical device manufacturers is that regulations often change. They change every few years. Using Cockpit, Mediso can easily update their processes and easily check-in the regulations that apply in Mediso-marketed areas . This signposts the regulations that are required and the user can easily navigate these and ‘switch’ on or off the ones that apply.
Because manufacturers in the medical industry need to be able to act as quickly as possible to change circumstances, a tool like Cockpit or Compass allows them to react to the developing world of regulations and compliance, while continuing to demonstrate safety and efficacy in use.
This highly adaptive way of selecting the best options provides companies like Mediso with an immensely powerful tool for future proofing processes and products, and allows them to keep pace with the changing needs of regulators, and to keep ahead of the market and competitors.
Read the full case study here.