Regulatory Surgeries Launch
IMed launches Free Weekly Regulatory Surgeries!
Have you ever spent more than an hour trying to resolve an emerging Quality or Regulatory query for yourself? According to IMed’s recent poll, many manufacturers have done just that.
Maybe you’ve eventually found the answer, or at least believed you had; but wished you also had the peace of mind you get from confirmation by a regulatory expert?
We’ve talked to clients, who were in exactly this situation. Some ended up calling a consultant for their advice in the end anyway. Others did lots of work, based on a misinterpretation of a regulatory communication, an update, or regulatory requirements of a potential new market. Then later found themselves needing to correct things fast to meet a commercial milestone. So – going it alone can be stressful and counter-productive.
But the truth is that most manufacturers don’t have every kind of resource they might need for every single regulatory challenge they might face – of course not; it wouldn’t be economic. Yet they don’t always seek the advice of a professional consultant, as they fear being heavily charged or getting embroiled in having to sign up to a contract. So, they don’t make that important call and just hope they’ve interpreted their situation correctly.
We’ve wanted to find a way of helping clients decide if they need to act on emerging regulatory conundrums without charge, as a way of giving back to the industry that’s benefitting us, as we continue to grow our business. We want important medical devices to stay on the market and help patients and care systems, so if that means a bit of friendly guidance off the clock, we can cope with that.
IMed already ran 3 successful Regulatory Clinics in 2021 for medical device communities, who we work with and through these we’ve supported;
– 3 Med Tech start-ups with grant funding or investment applications
– 2 UK manufacturers how to prepare their UK/EU products to meet US FDA requirements
– a number of software manufacturers, who suddenly found themselves with an app that turns out to be a medical device and attracts Quality and Regulatory obligations for them, of which they had no experience at all!
So, after these successful initiatives, we’ve now decided to broaden the events to help as many IVD and medical device companies as we can, by launching IMed’s Weekly Regulatory Surgeries, every Thursday!
From next Thursday, 3rd February 2022, Medical Device and IVD manufacturers or distributors will be able to book a 30-minute appointment with IMed and receive guidance on their regulatory queries from one of IMed’s Quality, Regulatory or Clinical Writing experts – absolutely free!
All you need to do is click on the link below, enter the calendar on your chosen Thursday of 2022 and select an appointment. The booking process will ask you to tell us about your query, so do give as much information as you can, so that we can field the right expert AND find any suitable links or information to help you. And I’ll do the rest!
Whether you want to know if you have an adequate Clinical Evaluation, or what your obligations are under IVDR beyond May 2022 or even what you need to do to get your product to a new market, just book into one of our surgeries and we’ll set you on the right path.
Remember – IMed’s Thursday Surgeries are every Thursday and completely free, so don’t worry about whether you are taking the right regulatory steps – find out for sure by clicking on the link and booking your appointment now! ‘We’re listening…..’
IMed Business Development Director