OUR CAPABILITIES

Turnkey Services for Medical Device Manufacturing & Distribution

Ease Healthcare offers specialized support to help diagnostic and screening innovations reach the U.S. market efficiently and in full compliance with regulations.

Your Commercialization Partner in the U.S. Market

Whether you need support with vendor selection, regulatory compliance, quality management, or U.S. distribution, our integrated approach ensures your products are positioned for success.

You can engage us for individual core services or as a turnkey operational partner through our Life Cycle Performance Management (LCPM) program. Backed by experienced teams, FDA-registered facilities, and robust quality systems, we help health technologies move from concept to patient care—faster and with greater confidence.

Core Services

CRO Management

  • Oversight of Clinical Research Organization (CRO) processes

  • Coordination with international manufacturers, including in China and across Asia

  • Support with regulatory and clinical documentation for FDA submissions

U.S.-Based Manufacturing

  • FDA-registered 30,000 sq ft facility with a 3,000 sq. ft. ISO Class 8 certified cleanroom with continuous temperature and humidity monitoring and control

  • ISO 13485:2016 certified quality system

  • Final product assembly for partners not requiring full-scale production

  • Automated high-speed production machines for lateral flow test kit manufacturing, with a monthly capacity of 3.3M tests for one-shift operation

  • Robust Quality Management Systems in place

Third-Party Logistics (3PL)

  • 18,000 sq. ft. warehouse facility in Brea, CA, with multi-zone real-time temperature and humidity monitoring and control

  • End-to-end shipping, receiving, and return logistics

  • Bonded warehouse for import/export management

  • Capacity to fulfill over 15,000 orders daily 

Life Cycle Performance Management (LCPM)

Originally developed as an internal operational model, the Life Cycle Performance Management (LCPM) program is now offered as a comprehensive turnkey service for organizations bringing high-quality medical devices to the U.S. market. Designed to support companies throughout the commercialization process, LCPM provides end-to-end guidance across three critical stages—product identification and licensing, manufacturing and regulatory management, and distribution and logistics—ensuring a streamlined, compliant path to market entry.

  • Stage I

    Product Identification & Licensing

    ☑︎ Identification of qualified foreign manufacturers & suppliers

    ☑︎ Vendor negotiations and certification review

    ☑︎ CRO oversight and FDA clinical trial coordination

  • Stage II

    Manufacturing & Regulatory Management

    ☑ Manufacturing and assembly at an FDA-registered, ISO 13485–certified facility

    ☑ Adherence to a robust FDA- and ISO-compliant quality system

  • Stage III

    Distribution & Logistics

    ☑︎ Strategic logistics planning, warehousing, and returns

    ☑︎ Fully managed shipping and receiving infrastructure

Our Commitment to Quality

All operations are governed by a unified Quality Management System (QMS) designed to meet or exceed regulatory requirements and customer expectations. Our QMS supports our core objective: delivering high-quality products and services—on time and within budget.

We apply advanced engineering, manufacturing, and information systems to continually improve how we serve our partners. Across all operations, we uphold the Four C’s that define our quality commitment:

  • Commitment

    Commitment to integrity, safety, and operational excellence.

  • Customer

    Focus on exceeding Customer expectations.

  • Continuous Improvement

    Ongoing Continuous improvement of systems and services.

  • Compliance

    Full Compliance with regulatory and quality standards worldwide.

Regulatory Compliance

We maintain a robust Quality Management System (QMS) aligned with global regulatory standards to ensure the safety, effectiveness, and reliability of all medical products. Depending on each product’s design and development requirements, our QMS complies with the following:

  • ISO 13485 – Quality Management Systems for Medical Devices

  • U.S. FDA 21 CFR Part 820 – Quality System Regulation (QSR)

  • ISO 14971 – Application of Risk Management to Medical Devices

Our compliance framework is designed to support regulatory submissions, ongoing manufacturing, and product lifecycle management in accordance with industry best practices and applicable laws.