A review by Nancy Consterdine, Director and Co-founder of IVDeology Ltd
As we near our 2nd birthday it seems like a good time to look back at our successes over 2019. We started out in January having our 1st anniversary, at the time the team still stood at 2, myself and Stuart but that was very soon to change.
Late January saw Anne-Marie Turner join us as a project manager working to deliver a QMS, Design History file and consequent Technical File for a small start-up funded by the Boost4health initiative (in association with Kent County Council). This partnership proved successful with CE mark approval being delivered in December 2019. We’re very proud of this success and our continued association with ExSeed Ltd.
Nancy presenting at he TOPRA Masterclass
February saw Stuart and myself presenting lectures for the TOPRA IVD Masterclass, this is always an interesting few days and we normally end up gaining insights into a subject area or two.
March brought our first international contract with providing IVD Regulation training to a large US based manufacturer. We were fortunate enough to be able to also take our families with us and spend a couple of days enjoying New York before work started in earnest. We delivered bespoke, quality Management focussed training around the IVD Regulation and the major changes impacting the industry.
We also we able to have a half day practical implementation workshop with them which proved very popular.
A family outing to see the Statue of Liberty in new York
March also saw a trip to China; we were supporting workshops on building Technical Documentation in compliance to IVDR for transitioning (legacy) products.
April brought a new contract for me, working with a company developing a purely digital medical device. I was there to support a major revision of their QMS and to guide them in building the technical documentation to ensure transition to Medical Device Regulation compliance. This contract ran for 6 months and whilst providing me with valuable experience it did remove me from IVDeology, an experience that Stuart and I have agreed should not be repeated for either of us. Our focus is the successful growth of IVDeology.
May was an extremely important month, Joanna Angell joined as Employee No 1. Jo brings 18 years of experience within the IVD industry and has been a valuable asset since she joined. Two became 3 and we started to look to the future, planning for the 2nd half of the year. As a company we want to support local business and flexible working, giving opportunities to experienced, valuable professionals who, for whatever reason, need flexibility in their working day.
May also saw us back in the United States, this time to run more implementation focussed training sessions and workshops. We delivered Executive level training on the business impact of IVDR, this regulation is not just for transition, it is for life.
June and July brought well-earned holidays and the team steadily working to deliver on the current projects. July was also the month that Stuart visited the fourth country of the year, Japan, for more transition workshops.
Stuart also presented to the Westminster Health Forum on behalf of the British In Vitro Diagnostics Association (BIVDA) on the current climate within the IVD industry.
Stuart as the vice chair of the BIVDA RAWP Seminar
August brought a trip to our third country of the year, Poland, to deliver ISO13485 training and initiate the project with another start-up. Working with them to initiate their QMS right at start of design and development shows the CEO understands the importance of quality.
September brought the end of my 6-month contract, I could focus fully on IVDeology again and we took the chance to spend a week looking at the business and forming a development plan.
October brought trips to the US and Poland again and also the BIVDA Seminar which was held in Manchester. We were both presenting, and Stuart was particularly busy in his role as Vice Chair of the Regulatory Affairs Working Party. There was an increase in the number of delegates again which I think is indicative of the increased momentum as we move towards the IVD Regulation transition deadline.
Nancy hosting an 'ask the experts' session on software at the BIVDA RAWP Seminar
November saw one of our projects conclude with the delivery of a CE marked device. This was an important milestone for us. We also delivered more bespoke training courses in the US under the IVDeology name and in London for Management Forum. We also moved into our office which is situated in the Historic Dockyard, Chatham.
December was not the quiet wind down we were expecting as the end of the year approached. We were busy with our existing projects and also excited at the conversations we were having for possible new projects and collaborations going forward. We took time to really review our ongoing resource and made plans for the new year.
Stuart me and Joanna at the BIVDA RAWP Meeting in December (with Christmas jumpers!)
So as the 19th January approaches we can look back and say that 2019 was a very successful year for us. We are also looking forward to another busy year for the growing IVDeology team. We will be concluding some projects and obviously working on some exciting new ones and we sincerely hope it will be just as rewarding.