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Medical Devices and UDI

 Samarind RMS for Medical Devices

The Samarind RMS Medical Devices solution offers purpose-built integrated functionality to help keep your products and facilities on the market and generating revenue.

Utilising our Single Place of Truth approach, RMS

  • Provides support for the full range of Medical Device companies from the smallest to the largest
  • Records worldwide device and facility registrations, approvals and notifications
  • Provides full support for the EU CE mark procedures, including automatic generation of the Declaration of Conformity (DoC)
  • Integrated UDI and related data promotes efficient GUDID communication with FDA
  • Supports the co-ordination of complex regulatory activities in both centralized and highly geographically dispersed teams
  • Integrated, secure EDMS with archiving capabilities
  • Offers sophisticated analytical capabilities across your integrated regulatory knowledge base

 

Optimising Standards Compliance

Similar to its pharmaceuticals counterpart, the Medical Devices industry is confronted by a constant stream of regulatory changes. The introduction by FDA of the Unique Device Identifier (UDI) and the requirement for GUDID access to submit information concerning a device (unless subject to an exception or alternative) is already bringing changes for companies marketing devices in the USA. Not to be outdone, Europe’s EMA is introducing the Medical Device Regulation to replace the Medical Device Directive. This too will introduce a “UDI” – the question is whether it will be the same as the FDA’s!

So, faced with these changing regulations, all overlaying the same basic data, how should companies remain or become compliant at the same time as being efficient? Samarind’s Single Place of Truth™ approach means that you can manage all of your medical device regulatory information in one place. So, for information that is relevant to multiple regulators, you change it once and then have the system guide the necessary communications to the regulatory bodies. This reduces the chances of different information going to different regulators as well as meaning you only have to make one change.

On top of this, for more complex changes, our project planning capability enables you to manage multi-step changes across a global workforce, keeping activities in step as well as the data they are using.

Contact us for a demo now!