About Us
Qualification and Skills
Over 10 years of experience in the medical technology industry and 20 years in industrial manufacturing. Deployed within various roles in the areas of manufacturing, research and development, risk management and quality assurance as well as technical documentation, qualification and validation.
We verifying the recommended minimum requirements of the authorities, which leading to approvals and licensing of a product manufacture. By ensuring the final product is free from contamination, that it is consistent in its manufacture, that its manufacture is well documented and that the personnel are well trained, and that the product has been quality checked frequently and not only in the final stages. Helping manufacturers to ensure their products are of consistently high quality for their intended use from batch to batch to avoid harm to the end user.
Experience
- Participation in project developments, extensions and change management
- Ensure feasibility and repeatable quality
- Qualification of suppliers, materials and facilities
- Review of current minimum standards and existing requirements
- Identification of critical control points, processes and parameters
- Risk analysis, file creation and update
- Initiation of corrective and preventive actions
- Implement verifications, test series and studies as well as the preparation of required documentation
- Draft training materials and presentations
- Team lead and staff trainings
