Everything under control

We are good. We are better. We are the best. Truth? Exaggeration? Illusion?

Don't be fooled by phrases like these. Demand proof. Trust is good, control is better.

For the development and improvement of our products, we have implemented a quality management system in accordance with ISO 13485 and Annex II of the European Council Directive 93/42/EEC concerning Medical Devices. dicomPACS^® has been CE certified (CE 0482) and is classified as a Class IIb product in terms of the German Medical Products Act. The 510(k) application for dicomPACS^® has been cleared by the US authority FDA under 510(k) No. K070618 and for dicomPACS^®DX-R has been cleared under 510(k) No. K091364. The German independent institute MEDCERT in Hamburg continually audits our quality management system.

All of this ensures that we have implemented and adhere to rigorously structured procedures in research, development, distribution and service, and guarantees you a constantly and verifiably high quality of all our products and services.

This is especially important for a diagnostic software like dicomPACS^® which is considered an active medical device and requires especially close monitoring.

We are happy to undergo any independent checks and controls to confirm
the quality of our products.

	Quality management system DIN ISO 13485:2003
	CE certification QS – 3048 in accordance with the European Medical Devices Directive 93/42 EEC Annex II (class IIb) for dicomPACS® and dicomPACS®DX-R
	510(k) FDA approval (No. K070618) for dicomPACS® as well as 510(k) FDA approval (No. K091364) for dicomPACS®DX-R
	CMDCAS certification (Health Canada)