Global Transfers
Efficient relocation, full compliance.
At RexMed, we specialize in the relocation of medical device manufacturing operations through a structured, validated, and fully documented Global Transfers service.
Global transfers
What is IT and why is it critical?
This process includes the transfer of design specifications, manufacturing procedures, tooling, and regulatory documentation from one site to another—locally or across borders—without compromising product quality, traceability, or compliance.
Key Benefits
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End-to-end project oversight.
We manage the entire scope of transfer—products, processes, tooling, and documentation—ensuring on-time, on-budget execution. -
Regulatory compliance across markets.
We assist with FDA, MDR, and other global authority updates, including DMR, labeling, and technical files. -
Validated manufacturing continuity.
We perform IQ, OQ, and PQ validations to ensure the receiving site meets all functional and regulatory criteria. -
Controlled equipment relocation.
We handle equipment packing, shipping, recalibration, and requalification at destination. -
Knowledge and team alignment.
We train receiving site staff and coordinate engineering, QA/RA, and supply chain teams for a seamless handoff. -
Structured risk management.
We apply FMEA and post-transfer KPIs to monitor quality and manage CAPAs where required.
Key Factors
- Experience executing cross-border or in-country medical device transfers with regulatory oversight.
- Capacity to requalify processes and conduct comparison studies between legacy and receiving sites.
- Internal quality system aligned with ISO 13485 and capable of supporting dual audits.
- Ability to document and trace every stage of the transfer process, including SOPs and Transfer Plans.
- Proven record of mitigating disruption through dual sourcing, inventory planning, and supplier coordination.
RexMed's Competitive Edge
Our binational infrastructure, combined with deep regulatory expertise and cleanroom-ready facilities, allows RexMed to execute global transfers with minimal disruption and full compliance. We take a consultative approach to every transfer project, working closely with your teams to ensure regulatory readiness, supply continuity, and cost efficiency. From early scope definition to equipment validation and documentation closure, RexMed delivers reliable global transfer execution tailored to OEM requirements.
Need a seamless cross-border transfer with full validation and regulatory support?
Request a customized assessment from our global transfer specialists.
FAQ
What steps are taken to prevent supply disruption during the transfer?
We implement dual sourcing strategies, raw material planning, and inventory buffers to maintain continuity.
How do you ensure product equivalence after transfer?
We conduct comparison studies and process validations to verify performance and quality at the new site.
Do you handle updates to regulatory documentation?
Yes. Our teams assist with DMR updates, technical file revisions, and labeling changes as required by global regulatory bodies.
Can RexMed support partial transfers like final packaging only?
Yes. We support both full and partial transfers depending on project requirements.
Does RexMed manage equipment and tooling relocation?
Yes. We include equipment transfer plans, shipping, calibration, and requalification as part of the scope.