Does your company need to outsource a company to manufacture your products and make things happen?
We can help you find a solution!
Tell us what you need and the expectations of your company, customers and stakeholders. We can take care of R&D, concepts, testing and manufacture.
We can turn your concepts into concrete and tangible items.
Your company already as the CE mark, but needs a manufacturing site? Then our OBL division is the answer.
The purchasing organisation (OBL) will be selling the device for the intended use under its own name and branding, it takes on all the legal responsibility for the device associated with being the manufacturer. which includes the requirement to follow the appropriate conformity assessment procedure for the risk classification class of the device, and the generation of a “Declaration of Conformity” and application of the CE mark.
Regulatory, consultancy and Technical support
Your company needs to approach international markets and needs assistance regarding regulatory affairs?
We can provide Technical support to our clients from the project to the implementation with a turn key solution.
Our regulatory affairs division can support your internationalisation process
regarding MD registration per country.