Home

Resume

I have worked in several companies e.g. Coloplast A/S and Radiometer Medical ApS.
Specific registration assignments which I have carried out or have helped carry out

  • Electromedical devices class I and II, according to the requirements in the EU, Easterneurope,Thailand, Japan and Canada.
  • Injectionpen class IIb, according to the requirements in the EU.
  • Dental equipment class I, IIa and IIb, according to the requirements in the EU.
  • Assistive technology class I, according to the requirements in the EU.
  • Biological Indicators medical devices class IIa, according to the requirements in the EU.
  • Equipment for operations, medical devices, class I,  according to the requirements in the EU.
  • Accessories to equipment for operations, class I, sterile, medical devices,  according to the requirements in the EU.
  • Antisnoring product, class I, medical devices,  according to the requirements in the EU.
  • Lice guard products, class I, medical devices,  according to the requirements in the EU.
  • Registration of blood gas meter (medical equipment) in relation to Canada.
  • Registration of an anti-rheumatic based on natural ingredients as food supplements/remedy in relation to Asia/Eastern Europe/the EU.
  • Registration of food supplements in Denmark/Scandinavia.
  • Preparation of files for cream as a cosmetic product in relation to the EU.
  • Registration of patches (class III, medical equipment) containing remedies such as silver or enzymes in relation to the EU.
  • Registration of patches (class IIb, medical equipment) in relation to the EU and the USA (510 k), South America, Asia and South Africa.
  • Registration of magnets and products containing magnets (class I, medical equipment) in relation to the EU.
  • Registration of magnet stimulators (class IIb, electro medical equipment) in relation to the EU.

Other assignments within the work as responsible for the registration I have carried out or have helped carry out

  • Preparation of information retrieval and documentation in relation to classification, risk control/toxicological assessment, clinical evaluation, preparation of registration documents and other applications.
  • Reporting of incidents or near incidents globally.
  • Evaluation of promotion material in relation to the Danish legislation.
  • Legislation monitoring, set up of databases with legislation concerning remedies, medical equipment, food supplements and cosmetics in relation to the legislation in the EU and the USA.
  • Pre-evaluation of new products/projects with regard to scientific literature, competitive products, patents and standards.
  • Review.
  • Evaluation of user’s manuals.
  • Preparation of guidelines for products.
  • Application regarding the Global Medical Device Nomenclature.
  • General contact to customers, suppliers and distributors.
  • Coordination of assignments.

Teaching/Guiding
"Overview of the roadmap to getting CE approval of medical equipment".

 Specific quality control assignments which I have carried out

  • Implementation of quality control EN 46001 for medical equipment.
  • Implementation of procedures for “Reporting of incidents and near incidents” and “Post-marketing surveillance”.
  • Implementation of ISO 9001.
  • Implementation of ISO/IEC 17025.
  • Implementation of sub procedures, e.g. for product design dossiers and clinical evaluation ISO 13485.
  • Implementation of procedures as regards working environment and environmental control.
  • Approval of products, including raw materials.

Examples of other assignments which I have carried out

  • Cooperation with project groups.
  • Drafts/drafts for negotiations/agendas/management of meetings.
  • Training.
  • Preparation of a scientific article.