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CE-marking
Mediteq offers consulting assistance for those who want to CE-mark a medical device. Mediteq assists with planning, training, project management and supervision in combination with advice so you gain an understanding of what the work with CE-marking entails and what the Medical Devices Regulations, MDR or IVDR, require.
After an initial planning and start-up phase, you decide how the work should be carried on – by yourselves or with continued support from Mediteq.
Management Systems
Management systems are the cornerstone of operations in a medical technology or in-vitro diagnostic company. The management system ties together the entire organization’s operations and activities, from personnel management to production and marketing. In order to manufacture and deliver medical technology or in-vitro diagnostic products, you are required to introduce a management system, such as the EU-market requires in accordance to MDR 2017/745 or IVDR 2017/746.
All businesses have different needs in a management system, depending on the organization and the products that the business develops. The path to an effective and representative management system is often associated with tricky questions and you can get lost between various standards and regulations.
By hiring Mediteq, you get access to solid experience in implementing and customizing management systems, a perfect companion on the way to your optimal management system.
Technical Documentation
Mediteq can help you with your technical documentation in order to meet the requirements of the regulations of MDR or IVDR. It is extensive work that is done with you and Mediteq. You have the knowledge of your product and Mediteq can guide you through it and also write. You decide how much Mediteq will do.
Registrations and Approvals
Do you need help registering your product in another country, what requirements are placed on it to get it on the market. Mediteq can help you with product approval in other markets – e.g. Canada, Australia, Asia. FDA applications e.g. 510k or presubmissions.