QUALITY

Our ISO-9001, ISO-13485 and QSR-820 FDA compatible production (US Food and Drug Administration) and technical facilities support you in your existing as well as in your new products. We have experience within the manufacturing and the regulations of FDA Class II products. Regardless of which industry you’re in, as a customer, you will benefit from our experience and technical expertise in the demanding medical industry. Your products will be handled by a dedicated team of technicians, committed to high quality and outstanding workmanship

In order to ensure that your electronics products are always produced in a high and uniform quality, we have achieved the following certifications and registrations:

DS/EN ISO 9001:2015 – Standard for Quality Management Systems.
DS/EN ISO 13485:2016 – Standard for Medical devices – Quality Management Systems.
FDA – registered Contract Manufacturer of Class II medical devices.
IPC – IPC A-610D 1/2/3 and IPC J001 2/3.

We have experience in manufacturing products according to the following standards and regulations:
UL – Worldwide safety consulting and certification company
ATEX – Directive 2014/34/EU

As a company certified according to ISO standards, we use D4InfoNet™ for the attainment of total electronic management of our complete quality system.

Download ISO certificate

Har du brug for hurtig hjælp?

Claus Jensen
+45 5928 0024
cj@danchell.dk