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.