| | | Your Partner for Medical Registrations |
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| Obtaining a CE marking for medical devices in-depth knowledge in the applicable product regulations and quality system requirements as well as practical experience in the regulatory strategy for your product. Experience and knowledge are also required for compliance to applicable standards and preparation and submission of the necessary documents to regulatory agencies to obtain marketing clearance.
So who are our clients?
They are medical devices requiring quality and regulatory assistance. Medical device companies located outside the European Union who need an Authorized Representative in order to be able to market their products in the European Union.
- Starting (University spin-off ) companies wishing to introduce a (new) device into the European Union, USA or on the Canadian market;
- Small or medium sized companies (product developers and / or legal manufacturers and / or sales organizations) wishing to introduce medical devices into the European Union, USA or on the Canadian market and either have not the expertise in-house or have a (temporary) limitation of capacity. This group includes product developers that design a product and have its production outsourced as well as contract manufacturers who use our services to help their clients with the market approvals;
- Sales organizations who wish to sell products already available on the market under their own brand name;
- Companies who want an independent opinion on their quality and regulatory performance. This includes services such as: internal quality audits, supplier audits, coordination of the product Risk Management, revision of Risk Management and CE Master;
- Companies proposing a significant change in the product design or claimed intended use for a product already approved. This includes the correct maintenance of the CE mark and CE Master File, FDA and Health Canada.
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