Conformity

As a manufacturer of medical devices, we face up to our responsibility!

The development and manufacturing along with the marketing of medical products is subject to highest requirements. These are in particular:
Implementation and observance of a quality management system in accordance with DIN EN ISO 13485
Certification and regular auditing of the company by a recognised institution
Clinical validation of the products
Full compatibility of sensor and monitor
Mechanical and electrical safety
Compliance with hygiene requirements
Maximum manufacturing quality
Warranty & guarantee

A quality management system is a legal requirement for manufacturers of medical devices in Europe. The requirements for this are defined in the EC Directive 93/42/EEC Medical Devices and in the standard DIN EN ISO 13485.

For global trade additional regulations and certifications apply, such as the FDA, CMDCAS and JGMP, which we have integrated into our quality management system and our approval processes.

We monitor our processes by performing regular internal audits in all operational areas with the goal of continual improvement. The TÜV Süd, as a Notified Body, audits our company on an annual basis.

Standards/Guidelines for Manufacturing/Application of Medical Products
Normen und Richtlinien für Herstellung/Anwendung von Medizinprodukte
DIN EN ISO 13485 Quality Management Systems - Requirements for medical products    
EC Directive 93/42/EEC 2007/47 Medical Device Directive (MDD)    
RoHS Directive on the restriction of certain hazardous substances in electrical and electronic equipment    
WEEE Waste Electrical and Electronical Equipment    
ISO 9919 (IEC 60601-2-54) The Biocompatibility of all used materials must be specified in the manuals, e.g. product documentation    
Verpackungsbereich
Verpackungsbereich
Verpackungsbereich
Certificates

Here you can download our current certificates:

EC Declaration of Conformity

Before placing a new medical device on the market, EnviteC issues an EC declaration of conformity in accordance with 93/42/EEC in the context of a conformity assessment procedure required by the Medical Device Directive.

With the declaration of conformity we confirm that the respective product is in compliance with the relevant provisions of the applicable directives. The preparation of a declaration of conformity represents an important element of our quality assurance system in accordance with DIN EN ISO 13485.

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