Reshoring for Medtech:
Strengthen Supply Chains & Compliance with MB&A

Bring critical manufacturing back home, optimize your supply chain, and mitigate risk—without sacrificing quality or speed.

Why MB&A is the right Partner for your Reshoring Strategy

MB&A helps medical device companies transition manufacturing back to the Americas with seamless integration of quality systems, regulatory strategy, and operational execution.

Strategic Sourcing & Total Cost Analysis

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We partner with customers to evaluate reshoring by factoring in tariffs, logistics, scrap, and quality‑driven defect rates to go beyond part cost.

Supply Chain Design & Risk Management

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We assess critical suppliers and map risk exposure. Our team helps you identify alternative domestic sources and build layered supply visibility to align quality and compliance across the chain.

Quality System Transition & Validation Support

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We’ll guide the transfer of manufacturing operations, process validation, device history record control, and QMS handoffs to ensure full FDA / EU MDR readiness during restoring.

Regulatory Strategy & Audit Readiness

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From 510(k) supplements to Canadian or EU changes necessary for domestic shifts, MB&A leads submission planning, labeling updates, and FDA audit readiness throughout transitions.

Implementation, Training & Workforce Alignment

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MB&A assists with workforce planning (e.g. apprenticeships), equipment onboarding, SOP training, and CNC / automation integration to meet reshoring goals efficiently.

Our proven process framework will save you time and money

  • Total Cost of Ownership, supply risk, regulatory readiness

  • Identify suppliers, regulatory path, validation protocols

  • Small runs, process validation, stability checks

  • Full transfer, documentation handoff, regulatory support

  • Ongoing performance tracking, audit readiness, continuous improvement

 

  • Deep experience in medical device manufacturing transfers, quality, and regulatory systems

  • Hands-on implementation for operational support, not just advisory

Why MB&A?

  • Cross‑functional approach integrating sourcing, quality, regulatory, and operations

  • Proven track record of audit-ready transitions with minimal compliance disruption

Ready to Bring Your Manufacturing Home?

Let’s partner on your reshoring initiative—from supply chain mapping to validation, quality systems, and regulatory readiness. Contact MB&A to explore a tailored plan.

Get Started Today