In other words – What a difference a year makes!
In November 2017, we received the news that we were being made redundant, this was where the idle chat of one day starting a consultancy business became reality. As December 2017 rolled on, the plans to start the company became more solid but we didn’t have a name. We liked the sound of Rochester View Consulting however it was pointed out that it sounded more like a retirement home! Then one day as Stuart was in the car with his son and thinking out loud around IVD and our ideology, his son shouted “idea daddy, idea!” The two words melded together and IVDeology was born.
IVDeology Ltd was registered at company’s house on 19 January 2018. We started building our quality management system, always with our company mission statement in mind
To provide a series of fundamental principles that can be used to achieve compliance to In vitro Diagnostic Medical Device and Medical Device regulations using a clear, pragmatic approach that can be easily transferred into the Quality Management System of any IVD or Medical Device company
Our vision statement seemed ambitious as we wrote it, although looking at it in January 2019 we have achieved two of the three aims already. We are fortunate to have good connections in the IVD industry and have found our membership of BIVDA and active participation with the Regulatory Affairs Working Party invaluable. We have been fortunate to have worked with a notified body and larger organisations but where we really excel is working with small start-up manufacturers and medium sized organisations. The chance to work with them, identify gaps and then deliver solutions to close the gaps is what we set the business up for.
We have also written and delivered several training packages based around the IVD Regulation and the impact on manufacturers which have all been well received. Helping organisations to understand where they will be impacted and then discussing possible ways to facilitate transition is interesting and rewarding, we hope to have more sessions like this in 2019.
It is safe to say IVDeology Ltd has developed further and quicker than we could ever have imagined as we were starting out last year. We can only say thankyou to colleagues past and present who have freely given advice and support during the year. Also thankyou to our clients, we have enjoyed being part of your organisations and working with you to give support and find solutions.