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Company profile

Sunrise Medical — building dependable clinical supply programs since 1984.

Sunrise Medical is presented here as a reliable partner for Consumables & Infection Control Products, with a practical operating culture built around documentation, lifecycle support, and clear communication for regulated care environments.

Heritage timeline

Milestones that shaped the quality system

  1. 1984

    First regulated clinical supply programs launched with documented release checks and customer-facing product records.

  2. 1996

    Quality management procedures aligned with the predecessor frameworks that later informed ISO 13485 medical device controls.

  3. 2003

    Expanded support for hospital networks needing lot-level traceability, IFU discipline, and repeatable procurement communication.

  4. 2010

    EU documentation packages reorganized for clearer technical file review and distributor onboarding across clinical markets.

  5. 2017

    Audit readiness program strengthened around complaint handling, supplier qualification, and CAPA response discipline.

  6. 2021

    MDR transition planning added more explicit post-market surveillance and product classification records.

  7. 2024

    Digital document routing improved access to IFU, UDI, certificate, and replenishment notes for multi-site buyers.

Patient Safety First

Product conversations start with intended use, care setting, infection-control context, and the documented boundary of what each supply item is designed to support.

Evidence-led Engineering

Specifications, substitutions, and packaging recommendations are tied to written records rather than informal claims or untracked verbal promises.

Lifelong Service

Support continues after the purchase order through replenishment planning, documentation refreshes, corrective action routing, and lifecycle transition notes.

Leadership

Cross-functional accountability

Chief Medical Officer

Chief Medical Officer

Reviews clinical-use language, risk communication, and care-setting suitability before customer-facing release.

VP Regulatory Affairs

VP Regulatory & Quality

Owns ISO 13485, UDI, supplier qualification, complaint handling, and post-market documentation discipline.

VP Field Service

VP Field Service

Coordinates response windows, escalation routing, replacement stock plans, and training refreshes for installed programs.

Chief Technology Officer

Chief Technology Officer

Connects product data, document access, and operational systems so procurement teams can work from current records.

FDA 510(k) pathway reviewCE MDR 2017/745ISO 13485:2016IEC 60601 awarenessUDI traceabilityPost-market surveillance

Talk to a clinical supply specialist.

Bring the product category, care setting, volume estimate, and documentation needs. Sunrise Medical will help turn that brief into a reviewable sourcing path.

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