Registration Services
We support you
The approval of products for the global market is one of our core competencies.
Our Service for You
As an international approval service provider, Ondal takes care of the following procedures for you:
- Approval of medical devices in Europe (CE marking)
- Approval of medical devices in the USA (FDA registration and listing)
- Preparation of necessary approval documentation
- Communication with admissions offices
Necessary examinations and tests that qualify your product for the corresponding approval procedures are carried out directly at Ondal. Extensive in-house testing guarantees the success of your products. We make it easier for our customers to find new product developments that are ready for the market and ensure that your future products meet all approval requirements.
Lighting systems
Monitor support
Supply systems
Ondal Certifications
Ondal meets all applicable international certifications for the development and production of medical products:
- Certified according to DIN EN ISO 13485, Quality Management System for medical device manufacturers
- Certified according to DIN EN ISO 14001, Environmental Management
- Certified according to DIN EN ISO 50001, Energy Management
- Directive certificate according to MDD 93/42 for class IIb products
- MDR certificate according to MDR 2017/745 for class IIb products
- Stage 2 approval for IECEE tests
Extensive inspection and testing options:
- Measuring equipment such as 3D measuring machines and scanners for testing components
- Spectrometer for material testing
- Test rooms for durability, impact and cable tests
- Test room for load tests with calibrated measuring devices
- Chemistry - test room for examining chemical resistance
- Acoustic measurements
Our standard portfolio products are approved for sale in major markets:
- Products go through the appropriate conformity assessment procedure for the European market and are marked with the CE mark
- Ondal is registered with the FDA in the USA as a market participant and our products are listed there
- Products are tested by accredited testing organizations according to the applicable standards, so that a CB report including certificate, an NRTL report including mark approval and an ILAC report is available
Upon request, we can enable the marketing of our products in other countries:
- Through a Free Sales Certificate (depending on the country including certification, apostille and legalization)
- Supporting the branch or distributor in your country to submit the documents required from our technical documentation directly to the responsible authorities