Medico ERFA groups

In 2013, Bolls and Ringby started the first ERFA group, which targets all manufacturers/distributors of medico products in Denmark.

In recent years, many new medical companies have started and at the same time the number of standards and other legal requirements that manufacturers and distributors of these types of products must meet.

We have seen an increasing demand for help to get safely and correctly to market these products. That is why we started the ERFA group, which allows the participants to acquire the necessary knowledge and help in an informal way.

The groups cover, inter alia, the following topics;

Technical file

Clinical/biological evaluation

Risk analysis / Risk management

Labelling and user guides

Market surveillance

Verification and validation in general

Quality management according to ISO 13485

News about standards

General knowledge sharing among participants.

At the meetings we discuss new and old topics within the above, in relation to all risk classes and types of equipment. There are often several smaller presentations from participants, Bolls, Ringby and possibly outside experts.

The groups meet 4 times a year around Denmark and registration is open on an ongoing basis

Bolls and Ringby have many years of experience with approvals in both electrical and non-electrical medico products and are also involved in the standardisation work.

Send e-mail with registration labeled ERFA to;   info@bolls.dk

Or look more at: https://www.regulatoryaffairs.dk/kurser-og-erfagrupper/