Deadlines keeping you awake?
Deadlines keeping you awake? Wish you had more staff? IMed can help you to optimise your regulatory pipeline……….without breaking the bank!
All businesses have to find a way to manage their short and long-term projects concurrently. And when staff changes occur, there’s a natural slowing down of progress during handover, whilst replacements get up to speed. This is of course assuming that you manage to find exactly the right person to fill the slot, before your current employee’s notice period is up! In short, managing change and a fluctuating workload is a constant battle and it’s hard to maintain the quality of the work done at these times. I’m sure this sounds familiarly frustrating. But think again – because that’s why consultancies like IMed exist in the medical device Quality & Regulatory field.
Some clients have seemed surprised that we are happy to just pick up their slack from time to time; it could be a stand-alone Clinical Evaluation Review, which has the potential to be the straw breaking the proverbial Camel’s back. Perhaps coaching a new team member through the compilation of a Technical file of a device they aren’t familiar with? Or doing a simple gap analysis on a job to put a new Regulatory Manager on the right road. Helping clients to manage their regulatory plan IS what IMed does.
Don’t get me wrong, our experienced full and part-time specialist consultants can’t wait to get their teeth into a huge project or a pile of complex regulatory documents – but you don’t have to call us with a full compliance job on a brand-new device from design to launch or give us a complete ISO13485 standard to write every time, to get us interested. Our raison d’être is to plug your gaps – when timing and resource don’t match – however small or random the task.
Clients often come to us half-way through a task, which has been giving their staff sleepless nights, due to a lack of time to complete them, a slight knowledge gap or a daunting level of complexity that causes them to doubt themselves. When we ask why they didn’t get in touch with us sooner, they sometimes say they’ve been ‘conscious of budget’. But we all know that compliance is absolutely critical in this industry, it’s one of those things that’s just got to be done. And isn’t it a false economy to run late with your compliance and potentially delay important early sales opportunities, which far out weight the cost of getting your documentation in order? What’s more, our expert is familiar with the regulations and will probably work faster, without your team’s other day-to-day obligations – so there’s an added opportunity cost to your own team’s time, if it’s not as productive as it could be, when deployed elsewhere.
You can pick and choose where we help and without a big company infrastructure to fuel here at IMed, you know our prices will always be competitive.
Some consultancies do like to go back to the beginning with every device or quality standard and this would naturally increase the spend. But not IMed. Because we’ve worked in industry ourselves, we know the cost implications of re-inventing the wheel. We always put our future relationships first, so will only advise you to do the work that’s absolutely necessary to keep patients safe; and then only charge you for the work which we actually do. So, if we are finishing off a partially completed job, or covering a regulatory role at arms-length for a period to give you time to find exactly the right candidate, it won’t make a big hole in your budget. We don’t even charge you for the first meeting to assess the task and always give you a price in writing before we start. So, you can rest easy.
If you have a temporary hiatus, with too many deadlines coming at once, a member of staff out of the business for a long or finite period, or even a skills gap on a new piece of regulation or discipline, one of our team can simply pitch in and become one of yours, until your workload/team gets back to normal. Just let us know about that file keeps getting kicked into the long grass and get us to finish it for you. Then you can focus on keeping devices safe and selling them like hot cakes!
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