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Precision you can trust — 100% made in the USA

Medisurge, headquartered in Grand Rapids, Michigan, is a vertically integrated, ISO 13485-certified contract manufacturer that delivers precision medical device solutions for OEMs and innovators across the healthcare spectrum. We specialize in low-volume, high-mix manufacturing, with end-to-end services that include CNC machining, cleanroom assembly, EO sterilization management, ISO-compliant packaging, warehousing, and distribution.

From first sketch to final shipment, Medisurge gives you the infrastructure, agility, and regulatory alignment needed to accelerate your device to market with confidence.

Why partner with Medisurge?

1. Fully integrated US manufacturing

Medisurge consolidates production under one roof, maximizing quality control and minimizing handoffs. We offer:

  • CNC milling, Swiss lathe fabrication, and lathe turning
  • Electromechanical and micro-welding assembly
  • Plastic component molding
  • Lean manufacturing across all departments

All work is performed domestically at our Grand Rapids facility to ensure full traceability, responsive communication, and U.S. regulatory compliance.

2. Cleanroom precision & lean practices

Our ISO Class 7 cleanroom supports high-mix, low-volume sterile assembly, while our Class 8 room ensures contaminant-controlled inspection. We specialize in:

  • Cardiovascular disposables (infusion sets, cannulae)
  • Blood management systems
  • Wound care and cryotherapy devices
  • Temperature control tubing

Lean workflows support efficient production and help reduce waste while preserving surgical-level quality standards.

3. Advanced CNC & Swiss lathe machining

We machine micron-level tolerance parts for:

  • Orthopedic implants (hip/knee)
  • Surgical instruments
  • Electrosurgical system components
  • Custom diagnostic kit elements

Equipment includes:

  • (3) 3-axis vertical CNC mills
  • CNC lathe
  • Swiss lathe
  • Tube benders, ultrasonic welders, solvent bonders, and robotic automation

These tools allow us to fabricate complex metal-based components with repeatability and cost-efficiency.

4. Sterilization management & barrier packaging

Medisurge handles every aspect of packaging and sterilization, offering:

  • Internal tray/pouch sealing in ISO 11607-compliant cleanroom
  • Ultrasonic cleaning and ASTM A967 passivation
  • EO cycle management with batch scheduling
  • Pre-/post-sterilization inspections and full documentation

By integrating customers into existing sterilization cycles, we reduce time-to-market by up to 12 months compared to traditional third-party coordination.

5. Regulatory & quality assurance expertise

Our QMS supports ISO 13485, FDA 21 CFR Part 820, GMP, QSR, and EU MDR standards. Capabilities include:

  • Design verification and validation (V&V)
  • Risk management documentation (DHF, DMR, DHR)
  • Nonconformance and CAPA tracking
  • Audit readiness and remediation

Our internal complaint rate remains below 1% year over year—well under the 3% industry average.

6. Engineering & prototyping support

Our in-house engineering team helps de-risk design and improve manufacturability with:

  • Design for manufacturability (DFM) & assembly (DFA) guidance
  • Rapid 3D prototyping and low-volume builds
  • Regulatory strategy, labeling, and documentation consulting
  • Supplier and testing lab coordination

We partner with your team at every development milestone, not just the production phase.

7. Warehousing, logistics & government fulfillment

Through our affiliation with Alliant Healthcare Group, we extend distribution through:

  • Government procurement programs (via SDVOSB status)
  • Group Purchasing Organizations (GPOs)
  • Climate-controlled warehousing and inventory control
  • Global shipping and customs documentation support

We offer full chain-of-custody tracking, pick-and-pack fulfillment, and both bulk and per-unit delivery models.

8. Veteran ownership & mission-driven culture

Medisurge is part of the Alliant Healthcare Group—a certified Service-Disabled Veteran-Owned Small Business (SDVOSB). Through the Patriot Promise Foundationâ„¢, we support veterans transitioning into civilian life, especially those impacted by PTSD. Our founder, USAF Major (Ret.) Bob Taylor, shares his personal mission in “From Service to Success.”

This veteran-led culture fuels our precision, accountability, and relentless commitment to improving lives.

Target markets & clinical focus

We serve a broad range of medical specialties:

  • Cardiovascular disposables
  • Electrosurgical system components
  • Blood management tools
  • Orthopedic implants
  • Cryotherapy & temperature control
  • Wound care
  • Cell & gene therapy disposables
  • Diagnostic kits and surgical tools

Whether you need a single-use component or a multi-SKU procedural kit, we have the technical range and documentation readiness to deliver.

Operational excellence: continuous improvement in action

  • Real-time scrap trend analysis and proactive CAPAs
  • Monthly metrics reporting with internal thresholds
  • Supplier auditing aligned to FDA, ISO, GMP, and GDP standards
  • Continuous review of workflows to enhance repeatability and reduce waste

Our quality team is made up of “quality heroes” who treat regulatory excellence not as a checkbox, but a responsibility.

Let’s build better together.

Medisurge welcomes outreach from OEMs, startups, and innovators looking for turnkey medical device manufacturing solutions. Our team is responsive, agile, and ready to launch your product before others hold their first meeting.