Product Quality – danumed Medizintechnik GmbH

RELIABLE QUALITY, SMART REGULATORY APPROACH

ISO 13485, RL 93/42/EWG, CE

Being a German medical devices company, we set high quality standards – safety for the patient, benefits for the user.

We achieve our high standards by using the best materials, extensive quality controls and precise documentation. Medical engineers trained in Germany develop and improve our products with high efficiency and in compliance with the highest quality criteria. For all our products, we only use raw materials and components that meet and exceed the strict German quality standards. Our manufacturing processes and our quality management system also work according to these criteria in order to produce top quality products for customers with the highest demands.

Our quality management system is certified in accordance with DIN EN ISO 13485:2016 and in accordance with Directive 93/42/EEC, Annex II. danumed Medizintechnik has a regulatory strategy for the company and also develops such a strategy for each individual product, or project. In this way, we ensure best product quality and quick regulatory implementation and CE marking – for our own products as well as for your customised product.

Quality assurance through Association activities

danumed is a member of the SPECTARIS Association – the German Industry Association for Analytical and Medical Technologies, Optics and Photonics. SPECTARIS represents the high-tech medium-sized business sector in Germany and gives its members a voice through political activities and industry marketing.

danumed‘s RA Manager contributes her expertise to the working groups „MDR“ and „Regulatory Affairs Discussion Board Medical Technology“.

Close to the standards / DIN & CEN

Since January 2019, we are part of the DIN Standards Committee Medicine and represented by our experts in the committee „NA 063-02-02 Catheters, Drainages“. In addition, we are proud about the membership of our expert in the European Committee for Standardization (CEN) group „CEN/TC 205 WG 16 Catheters“. The focus of these working groups are Enteral Feeding Systems – Design and Testing, ISO DIS 20695.

Britta Pirnay, Quality and Regulatory Affairs Manager at danumed Medizintechnik, talks to DIN about her work in the standardisation committees, current and future topics in the medical technology sector and what advice she has for companies wishing to become active in standardization. You can read the complete interview here.

Who is DIN?
DIN, the German Institute for Standardization, is the independent platform for standardization in Germany and worldwide. As a partner for industry, research and society as a whole, DIN plays a major role in helping innovations to reach the market.
Experts from industry, research, consumer protection and the public sector bring their expertise to work on standardization projects managed by DIN. The result of these efforts are market-oriented standards and specifications that promote global trade and improve security and communication.

Please see www.din.de/en for further information on DIN.