Examples of applications within the business area:
- X-ray equipment
- MRI (cameras)
- Inplants and implants
- Chromatography equipment for the production of, among other:
- Technical healthcare equipment
- Prostheses and aids
- Dental and pharmaceutical applications
- Critical and life-sustaining equipment
- Water purification and liquid purification
- Analysis- and diagnostics
Most articles have extreme specifications and requirements for quality assurance, cleanliness, documentation and traceability.
- Clean room ISO class 8
- Measurement and monitoring of particle contamination
- Measurement and monitoring of microbiological contamination
Resinit's manufacturing processes are metal and animal free to avoid contamination and comply with GMP (Good Manufacturing Practice).
We can help with material selection and offer manufacturing processes to meet requirements in eg:
- ISO 10993-5
- USP <87>
- USP <88> VI
- Change Control
- traceability according to SS EN 10204
- sterilization and autoclaving.
* Certification according to standard ISO 13485 in progress.