Danish Medical Devices Certification

DGM (Danish Medical Devices Certification) is an independent business unit within DS Certificering A/S

DGM (Danish Medical Devices Certification) is an independent business unit within DS Certificering A/S notified by the Ministry of Welfare for the approval of medical devices and in vitro diagnostic medical devices (IVD). The Danish Medicines Agency supervises our work.

We are a unit consisting of trained lead auditors and regulatory experts. Moreover, we have some 25 external experts to assist us in assessing several aspects in connection with product evaluations, such as: Biocompatibility, clinical documentation and risk analysis. The external experts are sometimes used in connection with audits carried out at client's premises.

Medical devices are divided into two groups:

• Active medical devices cover all medical devices which, in order to function, depend on an energy source e.g. hearing aids, X-ray equipment, CT-scanners and patient monitoring equipment.
• Non-active medical devices cover all other medical devices e.g. contact lenses and implants.

Moreover, medical devices are subdivided into different classes of risk, and DGM is authorised to approve products in class: Is, Im, IIa, IIb and III.

IVD medical devices
Medical devices for in vitro diagnostics can be described as a medical device, such as a reactor, an instrument, or a device, which is used for examining sample material from the human body, including blood and tissue samples, for the exclusive or primary purpose of providing information to ensure a correct diagnosis for patients.

ISO 13485 & ISO 9001
DGM is accredited by DANAK and can provide accredited certification in accordance with the above-mentioned standards for manufacturers of medical devices.

DS/EN ISO 15378:2007
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP).

QMI collaboration
DGM has a cooperation agreement with the Canadian Quality Management Institute (QMI). QMI is a significant player in the international market for certification of companies.
The objective of the agreement is:
Via DGM, to facilitate Canadian and US customers’ access to obtain the CE-mark in order to market their products in Europe.
To enable DGM's customers obtain the quality management system certification (ISO 13485 under CMDCAS) which is required in order for companies to obtain a device licence from Health Canada.

Taiwan
A collaboration agreement with the Taiwanese authorities enables DGM to audit against the specific requirements made of quality management systems in connection with product marketing in Taiwan.
Subsequently, the audit report from DGM would be incorporated in the documentation to be submitted in order to obtain a licence to market the product in Taiwan, as an alternative to having to send a copy of the quality management system to the authorities. Also, the probability that the Taiwanese authorities will conduct an audit of the company is reduced.

FDA inspections
As an appointed person (AP), DGM may conduct inspections of manufacturers of medical devices on behalf of FDA. . An inspection conducted by an AP is an alternative to the traditional FDA inspection. In most cases, it is up to the individual manufacturer to choose whether to use an AP or FDA for an inspection.

Combined audit/inspection
DGM can also conduct an audit/inspection of the company in accordance with the mentioned schemes as an inspection, thus saving the enterprise time and money.

Courses
DGM has extensive knowledge of the approval of medical devices which we readily share through open as well as customised courses.