What to Know
Medical device quality engineering encompasses the planning, process and tasks required to ensure the integrity of your medical device. The resulting Quality Management System (QMS) directs how all work is performed. We recognize that every QMS will be unique. We specialize in designing QMS programs for medical device manufacturing.
If your operation is large scale, you may need individuals with a specific area of focus—such as Six Sigma, medical device process standards or quality testing.
We can also help with troubleshooting if an issue arises within an operational quality system.
How We Can Help
I3 Infotek provides comprehensive quality services to cost effectively fit your timing and scope. We are the preferred consulting team for implementing effective, compliant quality assurance systems.Our experienced medical device engineers can direct or support:
- Regulatory documentation
- design or revision of quality testing protocols
- advise on all quality aspects for a regulatory compliant product
- Product and packaging sterility
- Production costs and material selection