Certified and tested

Our quality standards

Our comprehensive quality management system guarantees compliance with our quality standards from the development phase to delivery in all production, process and product stages.

Management Systems

  • DIN EN ISO 13485, Quality Management System for Medical Device Manufacturers (DQS Medizinprodukte GmbH)
  • DIN EN ISO 14001, Environmental Management (TÜV Rheinland)
  • DIN EN ISO 50001, Energy Management (TÜV Rheinland)
  • EU Quality Management Certificate
  • EU Technical Documentation Assessment Certificate

Compliance

  • IEC 60601-1 Ed. 3.1. (ANSI/AAMI ES 60601-1 CAN/CSA-C22.2 No. 60601-1) - Test reports issued by TÜV Süd and Underwiters Laboratories UL
  • Electromagnetic compatibility - Test report by accredited test lab acc. to IEC 60601-1-2 Ed. 4.0 (VDE)
  • MDD 93/42 EEC (Medical Device Directive) - Certified by notified body DQS (ID no. 0297)
  • MDR 2017/745 (Medical Device Regulation), MDR 2017/745, mandatory since May 26, 2021

Ondal System Components

Most Ondal system components, such as welded, CNC-machined and painted parts, are manufactured by us. Defined processes and regular audits ensure the same level of quality for supplied parts.  With our surface treatment and finishing processes, we guarantee the disinfectability of our products through optimal paint adhesion and a robust coating.

All products manufactured by Ondal undergo extensive quality and functional tests and are suitable for the European (CE certification) and North American (NRTL certification) markets. 

We ensure that our customers receive a product that meets the highest quality standards, is safe to use and has a long service life. Regular internal and external audits take place in all departments and at all process levels to consistently  guarantee our high quality standards.