Obligatory information in accordance with MDD (medical device regulations)


As a manufacturer of medical devices, we at MediTECH are legally obliged to inform our customers and partners about problems at easily accessible, public places. This relates to

  • safety-related problems with products

  • Product recalls

  • Cancellations of registrations, certifications and certificates by the authorities

 

In the past - i.e. since the foundation of MediTECH Electronic GmbH in 1996 - there has been no reason for such information. With all our efforts and the latest findings, we strive to maintain this standard and never make recalls necessary. 

Should any of the above-mentioned problems occur or callbacks be necessary, you will find information on this here.

About registrations and certifications concerning MediTECH and our products, you can find out under www.dimdi.de .

declarations of conformity

Here you will find the current declarations of conformity to our currently available products from our own production. For this reason, we do not reproduce the declaration in the operating instructions / instructions for use enclosed with our devices.

quality management

Our company has had a quality management system according to ISO 9001 and Directive 93/42/EEC as a manufacturer of medical products since 1998. Since 2007 we have been certified according to ISO 13485.

The suitability and maintenance of the certification is checked in annual audits by a body independent of us.