Frequently Asked Questions

We work with a broad range of medical devices including orthopedic implants, cardiovascular products, surgical instruments, diagnostic devices, and sterile disposables. If you have a specific product in mind, contact us to discuss feasibility.

Yes. Complexus Medical is FDA registered and operates under a quality management system that complies with 21 CFR Part 820 (FDA Quality System Regulation). We also maintain ISO 13485 certification.

Yes. We manage the entire sterilization coordination process, including selecting the appropriate method (EtO, gamma, E-beam), coordinating with accredited sterilization facilities, and supporting validation activities.

MOQs vary depending on the product complexity, packaging requirements, and materials involved. We work with customers on a project-by-project basis to find the right production volume for your needs.

Our quality system includes incoming inspection, in-process controls, final inspection, and full lot traceability. We maintain device history records (DHRs) for all manufactured products and can provide certificates of conformance.

Our primary manufacturing facility is located in Plymouth, Indiana. This central US location provides excellent logistics access for customers across the country.

The easiest way to get started is to contact us through our Contact page or call us directly. We'll schedule an initial consultation to review your product requirements, production volumes, and quality needs, then provide a proposal tailored to your project.

Yes. We can manage your entire supply chain, from raw material sourcing and vendor qualification through finished goods warehousing and distribution. Our goal is to give you a true turnkey manufacturing partner.