Advena strives to offer the highest levels of service, but don’t just take our word for it – here are some comments from clients who clearly believe we provide an excellent service.
Advena have acted as the EU representative for Aus Systems Pty Ltd since 2005. I have always found John and his team quick to respond to our enquiries and well informed when assisting with registration and regulatory matters.
Working with Advena has made our entry into the EU medical device market possible. They patiently and skillfully and timely respond to an endless stream of questions and gradually the path forward came into focus. We have traveled a long distance from the time we first contacted Advena to where we are now--on the brink of our EU launch. We will be forever grateful to the Advena Team and know that we have true experts to turn to when the need arises.
I have worked with Advena on the Regulatory side of our business now for more than 10 years. The service provided during this time has always been fully professional and supportive towards our business operation. With the ongoing and constantly changing EU requirements for Medical Devices we are reliant upon Advena for the wide ranging Regulatory knowledge and expertise that they continue to offer and support us with.
We have worked with Advena Medical for more than 2 years and throughout that time they have demonstrated their expertise in the medical devices sector and provided expert support for gaining ISO accreditation and the development and submission of Technical Files.
We gained ISO 13485 accreditation in mid-2017 and very recently gained our first virtual manufacturer CE certificate. In the current environment of changing and increasingly challenging Medical Device Directive requirements, Advena’s technical and regulatory support has consistently been excellent and professional. Advena also helped us with managing our interactions with the Notified Body to deliver successful outcomes.
I would unhesitatingly recommend Advena to any company who need technical and regulatory support.
Always responsive and willing to work with us. Has gone above and beyond on a number of occasions, and that has been very helpful when the need arises. Very positive experience.
Thank you for being as perfect as we need.
Nothing but great service for +20 year!
We have worked with Advena for many years now and have always received a consistently reliable, professional service. Their adaptability to increasingly challenging regulatory requirements is testament to the outstanding service they provide. I have no hesitation in recommending their Consultancy services.
We have been using Advena Ltd. as our EU Authorized Representative since 1998 and have been very pleased with the professional service and quick response to any inquiries we may have regarding the EU guidelines and regulations. The monthly newsletter provides a wealth of information and is a great tool for staying ahead of changes. We would recommend Advena Ltd. to other U.S. device manufacturers looking for EU regulatory services.
We have worked with Advena Medical Ltd for several years and it is due to Advena’s professionalism, regulatory experience and knowledge that we gained ISO13485 2012 from BSI in Nov 2016.
Working closely with Advena we were also one of the first companies in the UK to be accredited to ISO13486 2016 in Nov 2017 as well as gained accreditation to manufacture and release sterile products.
I would wholeheartedly recommend Advena Medical Ltd as an extremely competent medical device regulatory consultancy organisation.
We have been with Advena Ltd since 1998 and view them as a real friend to smaller companies trying to navigate the ever changing regulator landscape.
John Adcock and his team have always been there for us with quick and solid answers to our most challenging regulatory questions. There templates and expertise working with other small and medium size companies have helped us not only solve our own problems, but get us prepared for changes that are coming from over the horizon. The Advena Newsletter we get every month has been such an incredible asset for keeping us abreast of those changes, I often ask if I can share its content with or Trade Association. We have been with them almost 20 years, and have only, ever had positive experiences along the way working with them.
Fortuna Healthcare have been using the services of Advena Medical Ltd for a number of years in their capacity as product regulatory and technical compliance advisors.
Our experience with Advena has been an overwhelmingly positive one as our company has benefited from both their undoubted technical excellence and also first class customer service for which they have always proved to be amenable and receptive at short notice to our requests for information. As well as Advena’s attendance on site to support us with our new Quality Manual System we have also received ongoing telephone and e-mail advice as well as regular newsletters providing us with up to date changes in product related regulatory affairs – a professional service in an increasingly difficult marketplace.