New Blog available now on UKCA Consultation response from the MHRA. 

Dr Sam Decombel is the Co-Founder and Chief Science Officer of FitnessGenes Limited, a direct-to-consumer DNA testing company that analyses genetic data and provides proactive lifestyle recommendations tailored to an individual's fitness goals

In 2020, taking advantage of their pre-existing DTC platform and supply chain, they took an opportunity to launch a COVID testing service to meet an increase in demand for these services in the travel industry. Following changes made to the minimum standards for private providers of these services in August 2021, they were required to change the sample collection method, and register their sample collection kit as a new medical device with the MHRA. With the requirement becoming necessary at the peak of the summer holiday season, registration was time-critical.

Dr Sam Decombel told us: "IVDeology supported us through the self-declaration process from start to finish, providing us with all the information we needed to successfully complete our technical file and respond to enquiries and feedback from the MHRA. They were incredibly responsive to questions on the process, and their in-depth knowledge and experience meant we were successful in achieving registration at the first attempt, minimising the overall impact to our business." 

"- IVDeology has supported Genomtec since the beginning of implementation of the quality management system. They share their knowledge and experience with us and often suggest specific solutions to problems. Without their support, achieving positive results, such as obtaining certification or positive audit results, would be bigger challenge for us. " - said Kacper Lipiec, responsible for Quality Management System in Genomtec.

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