CLIN-r+ is reaching out to its fellow Medilink IVD and medical device manufacturers to help reduce pressure on QA and RA teams. After successfully launching a US Case Rounds on EU MDR and EU IVDR for medical device communities in 2021 we’ve realised the need is significant. So, we are bringing it to the UK Medilink member communities. Starting in March 2022 we’re offering complimentary time every Thursday for private case rounds discussions, for Medilink Members.
We know that Medical Affairs and Regulatory queries can take hours (if not days) away from work as normal and with ongoing regulatory changes like EU MDR and EU IVDR, this means that R&D, QA and RA teams are feeling the pressure more than ever.
We often hear clients find that the answer to a small query opens a bigger question. Such as with Clinical Data – when is a clinical investigation needed? OK, now we’ve established that we need a clinical investigation – what does that entail? Oh dear, now we need a medical affairs department, a statistician and clinical trial designing service… Or the time someone thought they had the answer only to miss a slight technicality and then had to redo numerous sections of various product Technical Files…
This is an ongoing conversation we’re having with manufacturers and the levels of stress are noteworthy. Often there are small matters that need clarification, or we uncover a significant workstream that just needs simplification in the form of a project plan which can be formulated in 48 hours. The number of cases of misspent resources and non-conformance findings are rising.
90% of the Medical Device market are SME’s that don’t have full time resource structures such as Medical Affairs and biostatistics. Even the blue-chip companies are relying more than ever on consultants and outsourcing resource-hungry workstreams such as Clinical Evaluations, Investigations and Device Validation Testing (yes, even the big boys don’t have a resource for every single regulatory challenge as the regulations and guidelines keep changing!)
CLIN-r+ can see the big picture that the impact of losing medical innovations on patients, care systems and society as a whole would have. So, this is our way to give back to the industry we are passionate about. We recognise that a bit of help off the books makes very little difference to us but may the impact it might make could be worth far more than a complementary 45 minutes of our time.
Simply email Medilink Midlands to secure your appointment and let us know what you’d like our insight on.
Article written by Jacqueline van Druten, Principal Consultant, CLIN-r+ Ltd consultancy.
For further information go to Clin-r.com or contact us directly: info@clin-r.com
Clin-R+ is a member of Medilink Midlands, the life science industry association for the Midlands which works to help companies set up, develop and grow. Free drop in sessions are only open to Medilink Members at present, and are limited to one per company.