Dorte Thulstrup Email & Phone Number

MedTrace is a Danish-based company developing equipment and medical devices for hospitals nuclear-medicine departments.

Regulatory responsible in corporate projects, generating and executing regulatory strategies.

Copenhagen Area, Denmark

Regulatory responsible for development projects of medical devices and combination product. Contribute to the corporate knowledge and awareness of regulatory requirements to combination products integrating components within medical device, drug, and general use regulatory classification.

Copenhagen Area, Denmark

Obtaining and maintaining registrations and market clearances for the product portfolio globally. Regulatory responsible in a range of development projects of anesthesia workstations and related medical devices from early development stage to CE marking and global launch.Establishing and maintaining technical files for CE marking.

Preparing and communicating regulatory strategies for efficient development and market access of medical devices including drug device combination products and products in the borderline of being cosmetic, drug or medical deviceRegulatory responsible in a number of projects developing medical devices from early concept phase to successfully obtaining.

Assisting companies by identification of the regulatory requirements for CE-marking and FDA market clearance of medical devices and in vitro diagnostic productsDeveloping GAP analysis and regulatory strategies with focus on technical documentation and quality management systemsEstablishment of quality management systems according to ISO 13485, ISO 9001 and.

Assessment of the technological and commercial potential of research projects in the field of Life ScienceCooperation with external partners on development of business strategies in view of future investment in the projectEstablishment and presentation of roadmaps for the executive management of NKTBusiness development and project management activities in.

Preparation of presentation material in connection with the due diligence process prior to the initial public offering by LundbeckData collection, analysis and compilation of presentation materials for senior management as the basis for strategy work in the organization

Modification of polymer surfaces for immobilization of proteins, DNA or cell cultureCharacterization of polymer surfaces (XPS, TOF-SIMS, AFM, contact angle measurement, FTIR)Application of statistical experimental design with the aim to reduce the variation in product quality which had periodically been found in the production Characterization of the.