Targeted monitoring of manufacturing processes and end products in medical technology is essential for patient safety.
The qualitative requirements for medical devices such as implants, instruments, apparatus, material and accessories have developed greatly in recent years in favour of significantly higher safety for patients.
Not only the manufacturers and suppliers are subject to this obligation, but also we as chemists and laboratory service providers take our responsibility seriously.
Our versatile offer includes not only high-performance laboratory analysis, but also individual training for the professional development of your employees.
With the new medical devices regulation (MDR, Medical Device Regulation), the demands placed on manufacturers are increasing. Biological safety and comprehensive technical documentation are essential requirements for the approval of your medical devices.
Medical devices come into contact with various process auxiliaries during the manufacturing process. This can result in the development of critical substances that are hazardous to health.
Topics for the professional support of your employees along the entire value chain
- Cleaning validation and process validation
- Methods in accordance with EN ISO 19227
- Inorganic, organic and particulate residues
- Q-documentation of validations in production
- Consulting chemical characterization
- Consulting cleanliness inspections
- Seminars on cleanliness testing
- In-house training
- In-house workshop