Medical device manufacturers need their own regulatory, quality & safety management platform


Medical device manufacturers have long been the neglected cousins of pharma companies in terms of IT systems that specifically cater to their needs, yet their ways of operating are very different – and so are their needs of regulatory, quality, clinical and safety information management. The complaint we hear most frequently when starting a conversation is, “It seems as though all vendors are just trying to sell us systems designed for managing drug products, imagining – wrongly - that they’ll also suit medical devices.”

That’s why Generis has developed a range of dedicated Medical Device-specific capabilities. Available via our our CARA Life Sciences Platform, these are designed from the ground up for Device companies – catering for Design History Files (DHFs), Device Master Records (DMRs), Device History Records (DHRs), FDA 510(k) pre-market submissions, EU Technical File, Clinical Investigations and Evaluations, Quality documents/QMS and more.


Making light work of compliance – while transforming operational efficiency

As well as keeping companies compliant with the latest requirements, thanks to CARA’s full support for device submissions and post-approval maintenance, we help Medical Device companies accelerate product development and shorten implementation times.

Highlights include:

· An accurate and secure repository for maintaining Regulatory, Quality, Clinical and Safety documentation and data;

· Continuous alignment with the DIA Medical Devices Model. A pre-configured package based on the DIA reference model for medical devices provides full support for the complexities of DHFs, DMRs and DHRs, as well as individual source documents;

· Support for business processes from planning through authoring to approval, submission and registration; and

· Device component testing management and documentation, including software and hardware components, with full end-to-end traceability across the platform.


Intuitive to use

The CARA Life Sciences Platform is modern, cloud based, easy and intuitive to use, and highly customisable - applicable across a whole range of content management scenarios. It means Medical Device Companies can satisfy all of their data, content and business process requirements with a single point of visibility, and recourse to one consolidated information lake – able to share and re-use data and document assets across multiple use cases.

All of this helps to keep the costs of software implementation and maintenance low. CARA also supports secure content collaboration with third parties, with easy tracking and reporting from end to end.


Why buy more?

The ability to satisfy multiple needs from a single, adaptable platform is crucial to CARA’s affordability. With one licence per user, spanning any number of applications and use cases, our secure, cloud-based platform avoids the need for manufacturers to keep spending afresh on each new software module, with the risk of having to invest in multiple licence fees over time, not to mention expensive integrations between different software packages.

Best of all, we make it possible for Medical Device Companies to move beyond complex, internally-developed systems, or ad-hoc processes based around spreadsheets. With CARA, they can lay firm foundations for ongoing systematic improvements - which both meet evolving regulatory requirements around registrations, traceability and safety reporting and support greater operational efficiency.

To find out more about CARA’s Medical Device-specific regulatory content and submissions management capabilities visit https://www.caralifesciences.generiscorp.com/medical-devices


Will Walker is a client delivery specialist at Generis, with a particular focus on the requirements of medical device manufacturers.