OMNITRON DQS CERTIFIED ACCORDING TO DIN EN ISO 13485
CUSTOMER-ORIENTED SYSTEM SOLUTIONS FOR MEDICAL DEVICES FROM A SINGLE SOURCE.
In order to offer the medical device manufacturers among our customers even more security in accordance with international standards, we extended our existing quality management system according to DIN EN ISO 9001 in 20012 by the requirements of the standard for medical devices. OMNITRON is therefore a special partner for medical device manufacturers, one who can meet all quality, documentation and traceability requirements with certification in accordance with DIN EN ISO 13485.
A dedicated risk analysis and evaluation of the “mobile power supply” component is one of our extensive services within the scope of packaging in accordance with DIN EN ISO 13485.
The selection of qualified pre-suppliers, high-quality materials and preliminary products is another essential component of our quality management system.
In accordance with our certifications, we document the individual tests during production.
The test certificate and declaration of conformity provide information on the conducted tests and results and confirm the conformity of the end product with the specified properties of the individual components.
We would be happy to show you which standard is suitable for your medical device during a visit to your premises. Or you can visit us at our production site and get to know our qualified assembly live.