Mediteq offers consulting services for you who want to CE mark a medical device. Mediteq support with planning, training, project management, and guidance in combination with advice to give you an understanding of the work required to CE mark a medical device according to MDR or an in-vitro diagnostic medical device according to IVDR.
After an initial planning and start-up phase, you decide how the project will be managed – with more or less support from us.
The quality management system (QMS) is the cornerstone of medical device and in vitro diagnostic operations. The management system ties together the entire organization’s operations, activities and results, from human resourses to production, delivery and marketing. To manufacture and deliver medical devices or in vitro diagnostic products, you are required to have a management system according to ISO 13485 and the EU regulations MDR 2017/745 or IVDR 2017/746.
All operations have different needs in their management system, depending on the organization and products handled. The path to an efficient and useful management system requires answers to many challenging questions and decisions, and it is easy to be confused by various standards and regulations on the way.
Mediteq has a service for you who want to check how well your technical documentation meets the requirements of MDR or IVDR. This service is suitable for new medical or diagnostic products that have not been reviewed before, but also for products that have been manufactured and sold under previous directives. To avoid submitting an incomplete application or, in the worst case, being denied your application, you can hire Mediteq as a pre-reviewer of your technical documentation. In this way, you can save both time and money with the Notified Body.
Mediteq has extensive experience in applications and product registrations of medical and diagnostic products in most of the markets all over the world, including 510k, PMA, and presubmissions in the US, as well as product approvals in Canada, Australia, and many Asian markets. We can handle all your product registrations, be responsible for a region or carry out a single registration for a specific market. Mediteq compiles the documentation needed for the application and manages and coordinates communication and collaboration with authorities and local representatives to obtain the license or approval. We also handle Free Sales Certificates, notarization, and legalization of documents when needed.