Business Details
Your Trusted Healthcare Contract Development Partner
MGS is a global healthcare contract development and manufacturing organization (CDMO) dedicated to transforming customer challenges into innovative solutions that improve lives. With a vertically integrated approach spanning design, tooling, automation, and high-volume manufacturing, we serve leading pharmaceutical, diagnostic, and MedTech companies. Our global footprint includes 12 advanced facilities across North America, Europe, and Costa Rica, featuring over 250,000 sq. ft. of cleanroom manufacturing space. We combine decades of industry expertise with ISO 13485 and ISO 14001 certifications to deliver precision components and end-to-end solutions.Our focus on speed-to-market, risk mitigation, and quality assurance has made us a trusted partner for complex healthcare programs. From early-stage design through final production, our teams collaborate to ensure regulatory compliance and technical excellence. Strategic capabilities include high-cavitation tooling, multishot injection molding, and custom automation systems tailored to healthcare applications. With a commitment to innovation and customer-centric partnerships, we provide scalable solutions that address evolving industry demands while maintaining the highest standards of manufacturing excellence.
Services
Healthcare Product Design
Precision Tooling
Custom Automation
Cleanroom Manufacturing
Medical Device Assembly
Diagnostic Consumables
Pharmaceutical Components
Regulatory Compliance
High-Volume Molding
Global Logistics
Highlights and features
- Global footprint with 12 advanced manufacturing facilities
- ISO 13485-certified cleanroom production environments
- End-to-end solutions from design to high-volume manufacturing
- Specialized expertise in healthcare regulatory compliance
- Proven track record with leading Pharma & MedTech companies
Associations and certifications
- ISO 13485
- ISO 14001
Services
Healthcare Product Design
Our human-centric design process transforms concepts into FDA/MDR-compliant medical devices. With deep R&D expertise, we guide projects from ideation through regulatory approval, ensuring usability and manufacturability. Specialized teams focus on drug delivery systems, diagnostic devices, and surgical instruments.
Precision Tooling
We develop complex, high-cavitation molds for medical applications using advanced simulation and 3D modeling. Our ISO-certified facilities produce multi-component and stack molds with tolerances under 0.0005 inches. Expertise includes hot runner systems and rapid tooling validation.
Custom Automation
Tailored automation solutions optimize production efficiency for medical device manufacturing. We design robotic cells for assembly, inspection, and packaging with 100% traceability systems. Integration with press-side automation ensures consistent quality at high volumes.
Cleanroom Manufacturing
Over 250,000 sq. ft. of ISO-classified cleanrooms support Class 7 and Class 8 requirements. Our controlled environments handle critical components for diagnostics, pharmaceuticals, and surgical devices with automated molding and particulate monitoring systems.
Regulatory Compliance
Dedicated regulatory experts ensure compliance with FDA, MDR, and ISO 13485 standards. We provide full documentation support, validation protocols, and quality management systems tailored to healthcare product lifecycles.
Questions
What industries does MGS specialize in?
We focus exclusively on healthcare, serving pharmaceutical, diagnostic, and MedTech companies with contract development and manufacturing solutions.
Do you have cleanroom manufacturing capabilities?
Yes, we operate over 250,000 sq. ft. of ISO-certified cleanroom space across four global locations for critical medical device production.
Can you handle complex regulatory requirements?
Our teams specialize in FDA and MDR compliance, providing complete documentation packages and quality systems for regulated medical products.
What tooling expertise do you offer?
We develop high-cavitation, multi-component molds with advanced hot runner systems for precision medical device components.
How do you ensure product quality?
Through ISO 13485-certified processes, statistical process control, and automated inspection systems integrated across all manufacturing operations.
Reviews (3)
We Are Awesome Gs Ppl
Feb 17, 2021
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Constant screaming and yelling by management on the supervisor level to the owners and upper managers--TERRIBLE work environment. No person that values their sanity should step foot in this place. unethical to say the least
Mark Gapinski
Oct 27, 2020
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Treatment of employees is terrible, 16 years of skills wasted there. One star is even too high of a rating
Aleksandr S.
Nov 06, 2018
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Cargo loading is terrible. Managers can not find a common language with subordinates. so do not rush to come in time, you may be late nobody will notice you.
