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Contract Manufacturing Excellence

Empowering Partners with Capacity for Complexity

EMS develops medical devices with customers and is a full-service manufacturer – from prototype development to production.

At EMS, manufacturing medical instrumentation and implants is more than our expertise, it’s our passion. From our approximately 100,000 square foot state-of-the-art facilities, experience and integrity come together to create an industry leader. Each member of the EMS team is dedicated to ensuring excellence throughout the manufacturing process. Our investment in the latest milling, turning, Swiss and EDM equipment reflects our commitment to put cutting edge technology to work for you.

Our Capabilities Are at Your Service

EMS provides a full-service manufacturing solution for complex medical devices, emphasizing quality, craftsmanship with dedicated capacity. The services include prototype design, verification/validation, production manufacturing, and specialized customization. Our advanced technology and efficient processes ensure reliability and precision in bringing the premium quality products to market. EMS utilizes a dedicated team focused approach for enhancing design functionality, manufacturability, and design quality.

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Product Design Engineering

Unlock the full potential of your ideas with our EMS Product Design Engineering services. From napkin sketch ideas to market-ready products, we provide innovative, erticient. and tailored solutions to bring your vision to life. Partner with us for cutting-edge design support and exceptional results

Prototyping

Accelerate your innovation with our cutting-edge prototype solutions. Experience rapid development, precision, and seamless integration. Partner with us to bring your ideas to life and stay ahead in the competitive market. Ask EMS how to turn your prototype into a production ready validation!

Regulatory Support

Elevate your designs with our top-notch manufacturing capabilities, leveraging cutting-edge CNC and Robotic automation technologies. Our skilled craftsmen, paired with state-of-the-art equipment, ensure superior quality and swift turnaround times. Collaborate with us for dependable, high-precision solutions tailored to meet your needs. If your product demands adherence to PPAP, Control Plans, PFMEA, or MSA standards, entrust us to fulfill your requirements. Then allow us to utilize our experience in dock-to-stock (Kanban) and VMI to ensure the security of your future demand.

Production/Precision Manufacturing

We understand you need a partner you can rely on to ensure your products get to market on time and on budget. A thorough manufacturing review process ensures that each production order is routed through our facility efficiently. Whether low volume prototypes or high volume production, our manufacturing relies on highly automated processes, precision machinery, and strict quality control to meet the demands of our OEM partners while ensuring compliance with regulatory standards. Our investment in the most technologically advanced CNC equipment enables us to manufacture with precision and repeatability when facing even the most challenging designs.

Assembly and Packaging

Assembling and packaging products requires careful attention to detail to ensure that each item is correctly put together and prepared for distribution. Especially with multicomponent instrumentation, high mix/low volume (HMLV) complex manufacturing involves producing a diverse range of products in small quantities, often customized to meet specific customer needs. This type of manufacturing requires flexible production systems and highly skilled labor to handle varying product designs and processes. HMLV complexity demands precise coordination of materials, equipment, and labor to accommodate frequent changeovers and minimize downtime. Effective planning and agile supply chain management are key to maintaining efficiency and quality in this dynamic environment.

Testing and Validation

Testing and validation in medical manufacturing are critical steps to ensure that products meet stringent quality and regulatory standards. This process involves rigorous test and measurement at various stages of production, from subcomponents to the finished product. Validation activities confirm that manufacturing processes consistently produce products that meet design specifications. Compliance with FDA and ISO standards is essential, and thorough documentation is required to demonstrate adherence. This ensures that medical devices or products are safe for use and effective in their intended applications, minimizing risks to patients and healthcare providers.

Certification

EMS maintains an ISO 13485-certified Quality Management System. Our digital QMS empowers us to tackle challenges seamlessly, encompassing training, Validation Master Plan, Risk Management, CAPA, and Document Control. For consistent outcomes, EMS upholds a stringent equipment and clean validation policy, subjecting each production lot to thorough first article, in-process, and final quality inspections

Our Capabilities Are at Your Service

EMS provides a full-service manufacturing solution for complex medical devices, emphasizing quality, craftsmanship with dedicated capacity. The services include prototype design, verification/validation, production manufacturing, and specialized customization. Our advanced technology and efficient processes ensure reliability and precision in bringing the premium quality products to market. EMS utilizes a dedicated team focused approach for enhancing design functionality, manufacturability, and design quality.

LEARN MORE

Product Design Engineering

Unlock the full potential of your ideas with our EMS Product Design Engineering services. From napkin sketch ideas to market-ready products, we provide innovative, erticient. and tailored solutions to bring your vision to life. Partner with us for cutting-edge design support and exceptional results

Prototyping

Accelerate your innovation with our cutting-edge prototype solutions. Experience rapid development, precision, and seamless integration. Partner with us to bring your ideas to life and stay ahead in the competitive market. Ask EMS how to turn your prototype into a production ready validation!

Regulatory Support

Elevate your designs with our top-notch manufacturing capabilities, leveraging cutting-edge CNC and Robotic automation technologies. Our skilled craftsmen, paired with state-of-the-art equipment, ensure superior quality and swift turnaround times. Collaborate with us for dependable, high-precision solutions tailored to meet your needs. If your product demands adherence to PPAP, Control Plans, PFMEA, or MSA standards, entrust us to fulfill your requirements. Then allow us to utilize our experience in dock-to-stock (Kanban) and VMI to ensure the security of your future demand.

Production/Precision Manufacturing

We understand you need a partner you can rely on to ensure your products get to market on time and on budget. A thorough manufacturing review process ensures that each production order is routed through our facility efficiently. Whether low volume prototypes or high volume production, our manufacturing relies on highly automated processes, precision machinery, and strict quality control to meet the demands of our OEM partners while ensuring compliance with regulatory standards. Our investment in the most technologically advanced CNC equipment enables us to manufacture with precision and repeatability when facing even the most challenging designs.

Assembly and Packaging

Assembling and packaging products requires careful attention to detail to ensure that each item is correctly put together and prepared for distribution. Especially with multicomponent instrumentation, high mix/low volume (HMLV) complex manufacturing involves producing a diverse range of products in small quantities, often customized to meet specific customer needs. This type of manufacturing requires flexible production systems and highly skilled labor to handle varying product designs and processes. HMLV complexity demands precise coordination of materials, equipment, and labor to accommodate frequent changeovers and minimize downtime. Effective planning and agile supply chain management are key to maintaining efficiency and quality in this dynamic environment.

Testing and Validation

Testing and validation in medical manufacturing are critical steps to ensure that products meet stringent quality and regulatory standards. This process involves rigorous test and measurement at various stages of production, from subcomponents to the finished product. Validation activities confirm that manufacturing processes consistently produce products that meet design specifications. Compliance with FDA and ISO standards is essential, and thorough documentation is required to demonstrate adherence. This ensures that medical devices or products are safe for use and effective in their intended applications, minimizing risks to patients and healthcare providers.

Certification

EMS maintains an ISO 13485-certified Quality Management System. Our digital QMS empowers us to tackle challenges seamlessly, encompassing training, Validation Master Plan, Risk Management, CAPA, and Document Control. For consistent outcomes, EMS upholds a stringent equipment and clean validation policy, subjecting each production lot to thorough first article, in-process, and final quality inspections

EXCELLENCE BY THE NUMBER

We take the lead in manufacturing instruments and and implants.

EXCELLENCE BY THE NUMBER

We take the lead in manufacturing instruments and and implants.

21

YEARS IN BUSINESS

+430

COMBINED YEARS OF EXPERIENCE ON OUR TEAM

7.7m

TOTAL TOP-LEVEL ASSEMBLIES MANUFACTURED

0

TOTAL COMPONENTS MANUFACTURED

Areas of Excellence in Medical Device Manufacturing

Instruments

Instruments

As a vertically integrated powerhouse, we are your ultimate source for medical devices, from single-piece designs to complex, multi-component constructs.

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Implants

Implants

Design and manufacturing of highest quality implants to enhance the Spinal, Orthopedic, Trauma, Extremities and Patient Specific sectors.

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Specialty Medical Devices

Specialty Medical Devices

Empowering our partners to innovate and expand deeper into the surgical suite with advancements in robotics, patient positioning, navigation, and beyond.

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Trusted by Leaders in Medical Device Innovation

Through our relentless pursuit of excellence, we drive groundbreaking advancements in medical device manufacturing, enhancing patient care worldwide.

Medtronic
Stryker
Johnson&Johnson Medtech
Globus
Smith & Nephew
Alphatec
Paragon 28
HighRidge
Seaspine

What Can We Innovate with You?

The possibilities are endless, share your vision with us today!