Manufacture & packaging in the medical device field
In-depth knowledge on the medical device as well it’s usage, risks and relevant regulatory requirements are an essential part before defining the required facility, cleanness level and manufacturing and packaging technologies. Information and data from the development teams should be handover to the Engineers to design the manufacturing, assembly and packaging processes properly.
Manufacture & packaging consulting services in the medical device filed
Clean rooms design
Production, assembly and packaging lines design
Advanced manufacturing, assembly and packaging technologies
Production, assembly and packaging process engineering
Production, assembly and packaging procedures writing
Product testing in manufacturing and assembly processes
Validation for manufacturing, assembly, packaging and cleaning
- Medical Device Sterilization Technologies
Equipment and medical device components cleaning methods
Production, assembly and packaging processes improvements
Procedures and policies writing
Biocompatible materials for medical devices
Medical devices manufacturing processes development
Employees training
Key process metrics (KPIs)
Risk analysis for the medical device
Preparation towards external regulatory audits
Supplier site inspection and qualification
Medical projects management
Medical device manufacturing and assembly troubleshooting
Other medical device services