Medical Device Assembly
Medical Device Assembly & Kitting in Minnesota
MDI provides compliant, precise medical device assembly and kitting — with the certifications and processes your quality team demands. From component staging through sterile packaging for medical devices, every step is documented, controlled, and built to withstand a quality audit.
Precision and compliance you can trust.
Competing in today’s medical device industry requires high precision, a clean, controlled environment, and flexibility to meet changes in supply and demand. You cannot afford errors, contamination, or delays when lives and regulatory approvals are on the line.
MDI delivers top-quality contract manufacturing and packaging services that instill confidence. No matter the project size or scope, we guarantee the highest quality on every run. Our white-room capabilities also support sterile packaging for medical devices that must ship ready for the operating room or point-of-care use.
Contract Labeling and Inspection Services You Can Trust
MDI provides packaging labeling outsourcing for industries where accuracy is non-negotiable. We combine expert hand assembly with advanced technology to deliver precise, repeatable labeling for any application.
From FDA compliance to simple retail barcodes, we ensure your products communicate the right information.
Certified Medical Assembly Capabilities
MDI operates with the strict compliance standards required by the medical industry. We are ISO 9001 certified and FDA registered for medical devices.
Benefits of MDI Medical Assembly
FAQs
MDI supports the assembly of a wide range of medical devices and components, including diagnostic components, disposable device kits, single-use instruments, sub-assemblies, and complete finished devices. Assembly ranges from manual hand assembly of intricate parts to semi-automated production of higher-volume components.
Yes. Sterile packaging for medical devices is a core capability at MDI. We offer heat sealing, induction sealing, and sterile barrier system (SBS) packaging using validated materials and processes. All sterile packaging work is performed under our documented contract packaging and sealing program.
Yes. Our controlled white room environment supports contamination-sensitive assembly and packaging with quality controls. Environmental monitoring, gowning protocols, and process controls are documented and audited.
Yes. Our labeling services cover Unique Device Identification (UDI) compliance, primary and secondary labeling, over-labeling for corrections or lot changes, and serialized traceability. We can integrate with customer data systems or maintain UDI records within our own quality system.
We regularly support customers from initial pilot builds of a few hundred units through repeating full production runs. Our workforce and facility footprint flex to match demand, and we work closely with customers on capacity planning during launches and market ramps.
Every medical project runs under our quality management system with documented work instructions, in-process inspections, and lot-level traceability. Records are maintained per regulatory requirements, and customer audits of our facility and processes are welcomed.
The best starting point is a call with our team to discuss your device, target volumes, packaging requirements, and quality documentation needs. We’ll scope the project, quote the work, and confirm any special validation activities before beginning a pilot production run. Contact us through our services quote form.
Partner with a proven medical manufacturer.
Located in Minnesota’s Medical Alley, MDI offers responsive service, 24-hour quoting, and maintains a 93% Net Promoter Score. We are ready to support your next project.
