What is Medical Device Consultancy?
The regulatory landscape for medical devices is complex and constantly evolving. Medical device consultancy involves partnering with expert regulatory specialists to provide the technical insight and strategic guidance needed to bring a product to market, maintain compliance, and manage risk effectively.
Advena Ltd simplifies this process for small and medium-sized enterprises (SMEs). Our regulatory experts provide tailored, cost-effective support throughout the entire product lifecycle — from concept, design and classification to post-market activities.
The Scope of Our Medical Device Consultancy
Our dedicated team delivers a comprehensive range of consulting and advisory services designed to help your medical device meet the requirements of key global markets, including the UK (UKCA), EU (CE Mark), and the US (FDA).
Why Partner with Advena for Consultancy?
Choosing a regulatory partner is a decision based on confidence. By working with Advena, you gain access to internationally recognised experts who simplify complex compliance and accelerate your route to market.
Award-Winning Authority
Recognised as Medical Device Regulatory Consulting Company of the Year 2025 by Medical Tech Outlook, we’re proud of our proven track record and leadership in the MedTech regulatory field.
Certifiably Compliant
Our own Quality Management System is certified to ISO 13485 – the international benchmark for medical device QMS. This means our consulting advice is built on systems that are robust, reliable, and fully compliant.
UK Regulatory Leadership
As active members of Medilink and the UK Responsible Person Association (UKRPA), we maintain close relationships with the MHRA and the wider UK Life Sciences ecosystem. This ensures we deliver up-to-date, authoritative guidance on UKCA and UKRP obligations.
Dedicated SME Focus
We specialise in supporting small and medium-sized enterprises. Our consultants translate complex requirements under EU MDR/IVDR and US FDA frameworks into practical, cost-effective strategies that suit your business scale and objectives.
Full-Cycle Partnership
Advena offers end-to-end regulatory support — from device classification and technical documentation to ongoing post-market surveillance — ensuring continuous compliance throughout your product’s lifecycle.
Ready to simplify your medical device compliance?
Get in touch with Advena’s regulatory experts today to discuss your project and explore how our consultancy can help you achieve market approval with confidence.
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 is the ideal partner for YUYU. Their quick communication, professionalism, and thoroughness make us highly satisfied. We 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.
