Today IVDeology is 6 years old! With the knowledge of impending redundancy Stuart and I (Nancy) started the business that would grow to be who we are today. When we celebrated our first birthday in January 2019 we had no idear how our company woud grow over the coming 5 years or the amazing in vitro diagnostic designers, developers and manufacturers we would encounter and have the privilege to work with.
So what have we achieved in our first 6 years?
IVDeology has grown to be a team of specialists who all work sharing our values Friendly, Flexible and Supportive.
We have built our Quality Management System which has just been recertified to ISO9001
We have worked with companies to deliver quality management services
o MDSAP Gap analysis/audit readiness
o ISO 13485 internal audits
o Building QMS systems to passing certification
o ISO13485 focussed training
o Audit support
We have worked with organisations who needed to add to their skills to meet the challenges of transitioning to comply with IVD Regulation 2017/746
o Gap Analysis
o Scientific Validity Reports
o Performance Evaluation Plans
o Performance Evaluation Reports
o Building Technical Documentation ready for review
o Group training events
o Company specific workshops – ask us anything
o One to one mentoring and upskilling
o Providing the Regulatory or Quality service until they onboard their own resource.
In 2020 we opened IVDeology UKRP Ltd to meet the neeeds of manufacturers outside the UK meet the requirements introduced by the UK MDR
So what changes have we seen in our 6 years of operation?
- The continuing development of the UK regulatory framework, having Stuart working within BIVDA on the Executive Committee and as Chair of the Regulatory Affairs Working Party gives first hand experience of those developing changes
- Regulatory deadlines have come and gone and been extended/modified and industry has had to adapt – we will continue to support in the transition
- Covid – This hit the IVD industry hard both during and after. Opportunity and distraction
- The accelerated development of AI into the IVD industry, we have a software regulatory focussed specialist on the team to support those developers needing regulatory advice.
- We have entered into some strategic partnerships to provide our customers with access to EU Authorised Representatives, Swiss Responsible Person support, Electronic quality management system software
We’d like to say thankyou to our team, past, present and extended and all of the amazing people and organisations we’ve had the pleasure of working with and continue to work with. We look forward to the next years adventures, we’d love to work with more of the industry so please do come and have a chat, no need is too small or too big – book time in with us by click here