All manufacturers, and in particular those assembling medical devices, want to supply their final customers with an impeccable, compliant and quality production.
Komax Medtech has this expertise.
With more than 50 complex applications designed each year, our engineers are more than familiar with all the newest test and inspection technologies, including vision systems for recognising complex objects, strength, torque, flow, leak and sealing tests.
This permits us to comply with the medical industry’s cGMP.
Aware of the medical industry’s strict requirements in order to guarantee the safety, purity and effectiveness of the medical device, Komax Medtech has set up a validation concept that is an integral part of the project’s progress.
Our validation engineers participate as soon as the specifications are received and follow the project up to the last SAT step.
This process, wholly compatible with GAMP methods, is entirely based on risk analysis which allows us to meet the medical industry’s cGMP and BPF requirements.
cGMP Clean Room Compliance
Comprehensive knowledge of class 10,000 to 100,000 for clean room production and a wealth of experience in using automated systems in aseptic environments.
Project success can be defined as the on-time delivery of a production system that meets or exceeds the customer's specifications.
Our critical success factors are defined as:
- Risk Mitigation
Our way of working is based upon a project based organizational structure, coupled with well-defined procedures. Obtaining in-depth knowledge of the customer's product and the related processes is part of our approach. Our customer is a permanent member of the project team, from the start through to the last milestone. Competence, open communication, partnership and a high level of technical know-how are the keys to success for the engineering of systems destined for medical and pharmaceutical applications.
PROJECT MANAGEMENT EXPERTISE
At Komax Medtech, our project managers and their teams are used to managing various projects, from lab line to very large production lines, including multi-sites coordination and full integration of OEM equipment:
- Lab & Pilot line
- High Volume line
- Line retrofits
- Production assistance
- Production before shipment
- Packaging integration
- Multi machine line with full integration (data collection, validation, supervisory system)
- Multi-site project with our sister companies (Malaysia and USA)