Nextec Medical UK Ltd is part of the Jenson Group of companies.
With over a decade of experience in medicines and medical device regulatory consultancy we are your trusted partner for market access in the UK.
Our expert team combines years of experience in industry and regulation with agile service provision and a tailored solution for our clients.
OUR SERVICES
We act as a UK Responsible Person according to UK MDR 2002
WHO NEEDS A UK RP?
Any manufacturer based outside of the UK that wishes to place their product on the UK market must register their device(s) with the MHRA via a UKRP.
The responsibilities of the UK Responsible Person are set out in the UK MDR 2002 and include management of registration, communication with the competent authority and facilitation of post market surveillance/vigilance processes.
Get in contact with us for further information about our services.
We provide a comprehensive post market vigilance service.
UK VIGILANCE SERVICES
We understand that vigilance and post market surveillance activities are a key part of a medical device’s development lifecycle. With differing regulations worldwide and varying requirement it can also be difficult to ensure all PMS are completed. Nextec medical provides a comprehensive post market and vigilance service supplying regular reports compliant to the requirements specified in UK MDR 2002. The content and frequency of the reports can be tailored to your needs.
Get in contact with us for more information.
RELIABLE FOUNDATION
NEXTEC Medical UK is part of the well-established Jenson Group founded in 2011.
STRONG EXPERTISE
Our regulatory affairs experts have years of experience in industry and in notified/UK approved bodies.
BROAD KNOWLEDGE
We cover all aspects of medical devices and work with our medical team for drug device products and devices incorporating medicinal compounds.
ALL-IN-ONE SOLUTIONS
Our broad in house team allows us to be agile and meet your requirements effectively.
regulanet® is a network of independent regulatory affairs consultancies with representation in over 90 countries throughout the world. The members of the network provide advice and assistance on national and international projects and marketing authorisation procedures, including the decentralised, mutual recognition and centralised procedures within Europe. The services offered by members includes all aspects of development, regulatory and market access in their respective countries.
Thomas Wood
Regulatory Manager – Medical Devices
Thomas joined the Jenson Group in May 2023 as a Regulatory Manager – Medical Devices. He has experience in notified bodies as an auditor and technical expert and has worked in both CE and UKCA marketing alongside ISO 13485, ISO 9001 and MDSAP.
Thomas has a bachelors in Applied Biomedical Science.
HOW CAN WE HELP YOU?
If you have a question or are interested in any of our services, please contact us.