MDD Turns 3
Year after year, regulations become increasingly complex. With the application and enforcement of the EU Medical Device Regulation [MDR] and EU In-Vitro Diagnostic Regulation [IVDR] there is a lot of pressure on Medical Manufacturers to ensure complete compliance with the regulatory requirements. The additional need for appointing a PRRC [Person Responsible for Regulatory Compliance] under these new EU regulations makes it mandatory for manufacturers in Europe to have a designated team/employee at their disposal who manages the process for regulatory compliance. We mustn’t forget that the role of EU Authorised Representative [EU AR] is no longer simply a post-box address. The EU AR shares equal responsibility with the non-EU manufacturer for the devices which the manufacturer places on the EU market. This extra legal responsibility for the EU AR means a significant increase in the cost of obtaining sufficient insurance cover.
But, why are we telling you all this?
Well, no matter what, our experts and teams continue to be successful in providing a complete regulatory affairs solution. Our ongoing services and support have helped manufacturers obtain full compliance with the mandatory requirements. By developing a robust regulatory strategy, we have supported spin-outs and early start-ups with the commercialisation of their ideas and putting their devices ‘on the shelf’. Our strategy reports have also contributed to these companies being able to raise funds for development and launch activities. Med-Di-Dia’s EU AR clients are in safe hands and in our role as PRRC we have achieved a 100% compliance rate for our clients.
Whilst we were busy being your Regulatory Risk Partners for Medical Devices, Diagnostics and Digital Health, we almost overlooked the fact that this particular spin-out (and baby) of Global Regulatory Services [GRS] has grown up and is Turning 3!
Med-Di-Dia Turns 3 today and we are thrilled.
Our Co-Founder/Managing Director, Bobby Deal on this 3rd Anniversary said, “Not long after our launch, the COVID-19 pandemic caused everything to go ‘topsy-turvy’ but despite this, we have continued to accelerate towards our vision to be the ‘go-to’ consultancy for regulatory and quality compliance expertise for Medical Device, Diagnostic and Digital Health companies. The Pandemic has been terrible for so many but within this darkness, a lot of good has also happened. Community spirit has been re-awakened and strengthened and I have seen this first-hand through Med-Di-Dia where we are collaborating with numerous organisations all with the common goal to get innovative, high quality and safe medical technology into the clinics and to the patient. None of this would be possible, however, if we didn’t have such a committed, supportive and highly knowledgeable team of employees who are the bedrock of Med-Di-Dia. 3 years is a key milestone and I look forward to the Med-Di-Dia ‘toddler’ growing into adulthood!”
Our Industry partners and colleagues are celebrating this day with #MDD3 across various social media platforms. As we celebrate this milestone, our Co-Founder/Director Greer Deal said, “It seems as though it was only the other day when Bobby and I identified there was a need for a niche consultancy to focus on the regulatory and quality compliance requirements for ‘all things MedTech’. Three years on and I cannot believe how time has flown by. There is a saying that “time flies when you’re having fun” - well … I must be having loads of fun! On a more serious note, however, I’m extremely proud of our team who have risen to the unique challenges thrown at them by the COVID-19 pandemic. They have proven how resourceful and determined they are to continue supporting and educating our clients, as well as the MedTech community as a whole, bringing ‘peace of mind’ to companies that their devices are compliant with the applicable regulations and international standards. I am privileged to work with such a wonderful group of people and I’d like to dedicate Med-Di-Dia’s 3rd Anniversary to them as a big ‘Thank You’ for their ‘grit and determination and for the many moments of laughter we’ve had along the way.”
Celebrations are a great opportunity to take ‘time out’ for reflection and also to thank our employees, our supporters and our clients for their commitment and support of our regulatory compliance endeavours. With the ongoing celebrations, our team is striving every day to make sure regulations do not affect your innovation!
Another Big Announcement is in this VIDEO!!
We cannot wait for you to see this!!!!
Our commitment towards the MedTech community remains the same. With ongoing enthusiasm and passion, we shall continue to be your Regulatory Risk Partners For Medical Devices, Diagnostics and Digital Health!
Together, we shall protect and enhance the care process for patients and end-users. It is because of patient safety that the Regulators adapt and update the mandatory compliance requirements. We are constantly on the ‘lookout’ for these changes to ensure that we continue to provide our clients with a full-service solution to obtain 100% compliance.
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