You can always feel when someone is truly frustrated.
Ed, my Father, was sitting across from me at dinner on a warm summer evening. And the stress was dripping off of his face. This was a few years back, but I can still feel it.
The topic of discussion tonight? Work, like usual. Ed had spent weeks reading the latest reg, EU MDR and preparing a presentation for the higher-ups that detailed his multi-year plan for compliance.
At the time, he worked for a massive manufacturer that had a portfolio of hundreds of SKUs, and was notorious for cutting corners. The day of regulatory reckoning was fast approaching, and Ed was adamant about revamping the CER team, the literature review process (that didn’t even exist for 90% of their tech files), and the plan for how to get these things written on time.
He laid it all out for his bosses, a full plan of attack complete with processes, hiring lists, and budgets. All in meticulous, yet easy to digest detail.
Can you guess what happened next?
They completely ignored him. Yep, that’s right. The ultimate decision was ‘let’s punt on this and see how strict they end up being with MDR’. Thanks for the powerpoint, Ed. Back to work.
There are two types of approaches to regulatory affairs and device compliance. The first approach is what was causing Ed so much stress. Where device compliance is an afterthought, a series of bureaucratic hoops to jump through, an anchor wrapped around the budget of big companies who need to ‘cut costs this quarter’.
The second approach is one of thought and precision. It takes a special kind of person to see the true art and benefits to medical writing. A dedication to getting the details right is vital, but above all else one must actually care.
So, you came to this page to see what our company was about? Well, It’s pretty simple.
We care about producing documents that matter for your devices. Whether it’s a CER, or a systematic literature review to shore up your EU MDR Technical file, we are on a never-ending quest to find the perfect process, the most dedicated and well-trained staff, the most state-of-the art software tools.
If you came looking for a chop shop with an army of faceless contractors, then I’m sorry but that’s not our thing.
If you’re looking for a partner who’s not afraid to get into the trenches with you and do the hard work, but also has the seasoned experience to advise and direct…then we should talk.
Our Team Your On Demand CER Writing Team
Depending on the size of your team, your needs will vary when it comes to the labor intensive CER process.
We’ve built a flexible and hybrid model here. Our team can handle the entire process end to end for you (full CER delivered with a bow on it) or we can collaborate with you as needed and simply provide guidance and support.
Literature Reviews and Post Market Surveillance (Vigilance Reports, PSURs and more) you’re welcome to handle internally, however in most cases we find that our team so is so efficient it’s cheaper and easier to leave it to them.
Our Expertise All Device Classifications in Europe/UK and the US
Our team’s experience is substantial. Together we have worked on devices across all classifications, with nothing but successful MDR submissions to show for our efforts.
For a full list of devices we’ve helped take to market with CER and PMS, please drop us a line and we’re happy to share.
Our Tools Systematic Literature Review Software for Medical Device
We couldn’t operate as fast or as accurately as we wanted with Distiller, so we built our own systematic literature review platform.
Designed exclusively for medical device literature reviews (that will meet the MDR standards of course), our platform requires no initial setup, and can have you cranking out your own systematic literature review in an afternoon.
I could go on and on about the features list (we are the only ones that search multiple databases for you, remove duplicates, and generate a full useable output in Word and Excel automatically) but if you’ve read this far, it’s best we show you.
Have a play with our system by booking in some time here. We’ll even load it up with search terms related to your device so you can see how everything works.
Ace your audit without breaking a sweat.
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