Accelerating market approval
By choosing LINK Medical as your CRO partner, you will gain access to our uniquely talented team of medical device experts, who can help accelerate every stage of product development. Medical devices encompass a wide range of products, with more than 500,000 approved for the European market alone. Some of these devices are strictly regulated and require extensive clinical documentation, whereas others have a classification that shortens the path to CE marking and market access. Understanding the specific regulatory and documentation requirements for your medical device is just one of the many challenges on the route to commercialization. With our profound knowledge of the regulatory landscapes across Northern Europe, we are well positioned to help you confidently navigate this challenge.
Flexible services where and when you need them
Our flexible service offering allows you to choose the product development solutions that will have the biggest impact on your business. For customers in the early stages of development, our strategy workshops will help you to refine your product concept and plan the most efficient route to market. For clinical stage customers, our consultants have broad experience in planning, conducting and reporting medical device studies. This process is supported by our unique clinical data management systems, that enable us to quickly compile all relevant documentation, and prove the safety and effectiveness of your product. Following market approval, we offer health economic analyses that will clearly demonstrate the economic benefits of your product to potential buyers.
Our proven project management model ensures the delivery of the right competencies – at the right time – to accelerate the development of your medical device. LINK Medical is the one source you will need to guide you through all the required regulatory and quality objectives for a successful market entry. To find out more about how we can support your medical device project, contact our Head of Department, Yngve Mikkelsen, at yngve.mikkelsen@linkmedical.eu.
Overview of Medical Device Services
Medical device requirements
- Local and international regulatory compliance
- Product/Risk classification
- Guidance for regulatory processes
- Risk management
Quality Management System (QMS)
- Quality systems
- Quality assurance
Documentation
- Creation of CE EU Technical File/Design Dossiers
- Medical writing
- Reviews of labelling and user documentation
- User-testing
Clinical
- Clinical evaluation reports
- Clinical study documentation
- Data management
- Statistics
Health economy evaluation
- Health economics analyses
Business area head:
Marie joins LINK Medical with a background in senior management and board membership within the CRO industry for over two decades. She holds a degree in Clinical Research and has longstanding experience in clinical development and regulatory strategy within the field of oncology, advanced therapies, biologics and gene therapies. She also serves the European Commission in reviewing the progress of Horizon 2020-funded clinical trials as an external expert and monitor.