About Us
Qualification and Skills
Our company focuses on verifying of the minimum recommended requirements of the authorities that lead to the approval and licensing of a product or service.
We ensure that the required documentation is available and complete, that the product or service is consistent and verified and that the personnel are well trained. We help companies ensure their products or services are of consistently high quality and understandable to the end user at all times.
Constant adaptation to the new regulations and revisions of e.g.; EU-MDR/ 2017/745, FDA21 CFR 820, ISO9001, ISO13485, ISO14971, ISO15378.
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
