A Major UK based Notified Body recently issued a major non-conformity to a medical device manufacturer in South Africa.
The auditor was not satisfied with the arrangements in place between the manufacturer and their EU Authorised Representative (EC Rep), in particular that their EC Rep was not a member of the European Association of Authorised Representatives (EAAR).
It should therefore come as a great comfort to our clients and prospective clients alike that Advena are not just a member of this respected organisation by are a founding member.
If this is an example of how Notified Bodies intend assessing a manufacturers EC Rep it should help make the decision process much simpler.
By choosing Advena as your EC Rep, you not only gain access to our regulatory experts, extensive experience and knowledgeable advice, you avoid this major non-conformity.