And now…EUDAMEDgate

The EUDAMED database and related compliance activities may be implemented earlier than previously expected. Now is the time for regulatory operations teams to engage with their cross-functional colleagues to determine when and how they will implement the regulatory data requirements within their business.

Join our own Kim Young, along with FDAnews, on May 20th

We are excited to be sponsoring the upcoming FDANews webcast titled Sustained Medical Device Regulation Compliance: Ensure Your Regulatory Processes and Tools are Fully Optimized. Join us on May 20th at 1:30 PM US EST to understand how to optimize your processes and tools to ensure that your regulatory operations can help get new products …

Thursday Thoughts….

Everyone, especially senior regulatory executives, has a preference for communication styles. Does your line manager request a departmental update via a one-hour presentation with lots of colourful graphics, an email composed of <200 words or a 10-minute telephone call? Regulatory professionals spend enough time justifying their role without supplementing any negative perception by presenting information to key stakeholders utilising the wrong approach……

Economic Operators: A new relationship with medical device regulations

Attention all manufacturers. Are you aware that if an Economic Operator (EO) considers your medical device to not be in conformity with MDR requirements, they are obligated to inform the competent authorities, thus impeding progress of your supply chain channels? The European medical device regulation places more direct responsibility on individual entities in the medical …

MDR Delay and Consequences for the UK

Please be advised that on the same day of this original blog posting, 24 April 2020, the MHRA amended the “Medical Devices: EU regulations for MDR and IVDR” which finally provided an official UK update on the delay to full implementation. The details may be found at https://www.gov.uk/guidance/medical-devices-eu-regulations-for-mdr-and-ivdr The European Parliament, with its infinite wisdom, …

A blog posting that doesn’t mention COVID-19 or MDR…

Welcome to my first posting for the RIMtelligence blog. As this is number one, let’s start at the beginning. Once upon a time, the regulatory function was not particularly well-defined and seemed to be more focussed on pagination than content. Are they Scientists? Medical Writers? Lawyers? Programme Managers? The answer of course is, all of …

RIMtelligence Goes Live!

Welcome to RIMtelligence, Instem’s new bi-weekly blog. We are excited to develop an online community where regulatory professionals can follow our subject matter experts to read and share insights about some of the most important matters facing all of us today. From regulatory updates and compliance, to learning about trends for streamlining processes to increasing …