Bringing a device to market is challenging. We are experts who consistently get you the results you need.
We are at the forefront of helping businesses adapt to the EU 1223/2009 Cosmetics Regulation, with cost-effective support.
Our experts will help you to create an efficient system that minimises overheads and complexity. Our services include support for ISO 13485 and the ACTIV online management system.
Helping you achieve compliance for over 20 years
Supporting you in achieving compliance
Who we are
What our clients say
We work incredibly closely with our clients, offering a bespoke tailored service so you get
exactly what you need from us
Advena remain the perfect partner for YUYU. From their communication, speed of turnaround and professional thoroughness. We are incredibly happy with their continued service and highly recommend their services.
We have developed a great partnership with the team at Advena since we started working together in early 2022. We especially value their honest and straight forward approach to our Medical Device Regulatory needs. What has been most impressive is their ability to really understand what we actually want, while also making regulatory and commercial suggestions that help our business now & for the future. I have been impressed with all my points of contact within Advena and their professional & friendly manner. I am very happy that we have chosen Advena as our Regulatory partner as we move into the next phase of our business growth.
Advena’s friendly, professional and knowledgeable team have been an invaluable resource for us, helping us with our CE & UKCA IVDR transition, ensuring the continuity of compliance that our customers require and rely upon.
Working with Advena meant that we could focus on what we do best - developing cutting-edge AI-driven clinical decision support systems - with full confidence that our products meet the necessary Regulatory and Quality requirements. Professionalism and efficiency of Advena’s consultants allowed us to rapidly enter new markets, whilst prioritising patient safety.
Great customer support from the beginning of the process. The team go the extra mile to assist and provide information. Information provided has been accurate, responses to queries were turned around fast, were clear and where necessary detailed enough for us to make informed decisions. We’re happy with the service Advena UK is providing us, and would definitely continue using their services.
We are very happy with the service we receive from Advena and from Jessica Ostle and her team. Communication is excellent and always timely. From the UK side everything has worked very well from day one until now. Very happy customers.
They are so kind and the services are so brilliant and active!
I found the process of signing up with Advena and then uploading and approving all our documentation (with respect to the role of UKRP) as quite efficient and well organised with good communication and support throughout the process).
Communications are quick and efficient, notifications of legislation changes are issued when applicable. Liaising with specialists/co-ordinators is painless (in comparison to my experience with other third parties). Advena have been very supportive and patient throughout, in a particular example with recent ‘’Brexit’’ artwork and UK RP changes for our cosmetic products. Internal projects have also been executed where Advena have demonstrated their continuous commitment to assist, engage and deliver. Advena have been a pleasure to collaborate with and their partnership is valued.