Quality

 
 

Quality Management

 

As an instrument supplier our focus is on quality - both, in engineering and manufacturing, we strive for the highest quality standards. Compliance to the well-established, though continuously changing standards is the key for our customers to reach product-approval in the relevant markets.


Sensovation is ISO 9001 and ISO 13485 (medical products) certified, supporting customers throughout product definition, R&D and product lifetime support.

 

 
 

Our products conform to safety standards for our worldwide customers, including CE conformance according to EU low voltage and EMC directives, and equivalent UL/CSA in North America.

We maintain a FDA 21 CFR 820 oriented quality system to support our US customers.

 

We are regularly audited and inspected by
    -  DQS Medizinprodukte GmbH (ISO-9001, ISO-13485, annually)
    -  Intertek & CSA (UL/CSA conformance, quarterly), and
    -  Customers

    -  Internal quality management

 
 

Quality Control

 

 

We manage quality and we deliver it:

-We check all parts at incoming inspection and maintain a supplier rating system.

-Our products are QC tested before shipment and we track all quality deviations.