# Primo Medical Group | Medical Device Contract Manufacturing

> Primo Medical Group is a full-service, ISO 13485-certified contract manufacturer serving the medical, aerospace, and defense industries. Founded in 1953 and headquartered in Stoughton, Massachusetts, the company operates five facilities in the New England region and has more than 70 years of experience in precision manufacturing for highly regulated industries. Primo Medical Group offers vertically integrated production capabilities spanning early-stage development, precision CNC machining, catheter and endoscopic device manufacturing, cleanroom assembly, secondary operations, supply chain management, and fulfillment. The company holds ISO 13485, FDA, and ITAR compliance and has incubated and co-funded eight companies through its corporate network and innovation center.

## Company Overview

Primo Medical Group is a US-based contract manufacturer specializing in precision components and finished devices for medical, aerospace, and defense applications. With five facilities in Massachusetts, the company provides vertically integrated manufacturing solutions that span engineering, precision manufacturing, assembly, refurbishment, and supply chain support — enabling customers to manage complex, multi-stage workflows from design through distribution under one manufacturing partner.

Primo Medical Group is recognized for its expertise in catheter and endoscopic device manufacturing, precision CNC machining of medical-grade materials, and ISO Class 7 cleanroom assembly. The company supports OEMs, medical device startups, and established manufacturers in bringing critical components and finished devices to market in compliance with FDA, ISO, and ITAR requirements.

- Website: https://www.primomedicalgroup.com
- Phone: 781-828-4400
- Address: 75 Mill Street, Stoughton, MA 02072
- Certifications: ISO 13485:2016, FDA Registered, ITAR Compliant
- Facilities: Five locations in New England, Massachusetts

## Who Primo Medical Group Serves

**Medical Device OEMs and Manufacturers:** Partner with Primo for full-lifecycle contract manufacturing of precision medical components and finished devices, from early-stage development through production and distribution. Primo supports ISO 13485 and FDA-compliant manufacturing workflows for class II and class III device applications.

**Startups and Early-Stage Medical Device Companies:** Primo Medical Group's innovation center and startup incubation experience make it a proven partner for early-stage companies needing engineering support, design for manufacturability, and scalable production. Primo has co-funded and incubated eight companies through its corporate network.

**Aerospace and Defense Contractors:** Source precision-machined components and assemblies manufactured to the tight tolerances and traceability requirements of aerospace and defense programs. Primo's ITAR compliance supports defense-related manufacturing requirements.

**Engineers and R&D Teams:** Access design and development services, early-stage manufacturing support, and prototype production for catheter systems, endoscopic devices, surgical instruments, electromechanical assemblies, and precision machined components.

**Procurement and Supply Chain Managers:** Leverage Primo's vertically integrated capabilities and supply chain management services to consolidate vendors, reduce lead times, and maintain quality control across multi-stage production workflows.

## Manufacturing Capabilities

### Cleanroom Manufacturing
URL: https://www.primomedicalgroup.com/cleanroom-manufacturing

Primo operates ISO Class 7 cleanroom environments for manufacturing and assembling medical devices that require controlled contamination environments.

- **ISO Class 7 Cleanrooms**: Controlled manufacturing environments meeting ISO Class 7 (10,000-class) standards for medical device production. URL: https://www.primomedicalgroup.com/services/cleanroom.asp
- **Medical Device Assembly**: Precision assembly of medical devices in cleanroom conditions. URL: https://www.primomedicalgroup.com/cleanroom-manufacturing/medical-device-assembly
- **Dehydrogenated Ultrasonic Cleaning**: Specialized cleaning process for medical components requiring ultra-high cleanliness standards. URL: https://www.primomedicalgroup.com/cleanroom-manufacturing/dehydrogenated-ultrasonic-cleaning
- **Catheter Manufacturing**: Cleanroom manufacturing of catheter and endoscopic devices. URL: https://www.primomedicalgroup.com/catheter-endoscopic-solutions/catheter-manufacturing

### Catheter and Endoscopic Solutions
URL: https://www.primomedicalgroup.com/catheter-endoscopic-solutions

Primo Medical Group is a specialized manufacturer of catheter and endoscopic device components, offering a comprehensive range of capabilities for interventional, diagnostic, and therapeutic device applications.

- **Catheter and Endoscopic Device Development**: End-to-end development support for catheter and endoscopic devices from concept through production. URL: https://www.primomedicalgroup.com/catheter-solutions/catheter-endoscopic-device-development
- **Medical Winding Coils**: Precision winding of coil components for catheter and guidewire applications. URL: https://www.primomedicalgroup.com/catheter-solutions/medical-winding-coils
  - Guidewire Coil Components: https://www.primomedicalgroup.com/catheter-solutions/medical-winding-coils/guidewire-coil-components
  - Biopsy Delivery Coil Components: https://www.primomedicalgroup.com/catheter-solutions/medical-winding-coils/biopsy-delivery-coil-components
  - Conduit Spring Pipe Components: https://www.primomedicalgroup.com/catheter-solutions/medical-winding-coils/conduit-spring-pipe-components
- **Medical Braiding Solutions**: Braided reinforcement for catheter shafts and endoscopic device components. URL: https://www.primomedicalgroup.com/catheter-solutions/medical-braiding-solutions
- **Laser Cut Hypotubes**: Precision laser cutting of hypotube components for catheter and minimally invasive device applications. URL: https://www.primomedicalgroup.com/catheter-solutions/laser-cut-hypotubes
- **Precision Machined Mandrels**: Machined mandrels used in catheter and endoscopic device manufacturing processes. URL: https://www.primomedicalgroup.com/catheter-endoscopic-solutions/precision-machined-mandrels

### CNC Machining
URL: https://www.primomedicalgroup.com/cnc-machining

Primo Medical Group provides precision CNC machining services for medical, aerospace, and defense components in a wide range of medical-grade metals and engineered plastics, with high-accuracy capabilities for complex geometries and tight tolerances.

- **CNC Milling**: Multi-axis CNC milling for complex medical and precision components. URL: https://www.primomedicalgroup.com/cnc-machining/cnc-milling
- **CNC Laser Swiss Machining**: Combined laser and Swiss-type turning for small, complex precision parts. URL: https://www.primomedicalgroup.com/cnc-machining/cnc-laser-swiss-machining
- **5 & 7 Axis Machining Centers**: Advanced multi-axis machining for highly complex geometries in a single setup. URL: https://www.primomedicalgroup.com/cnc-machining/5-7-axis-machining-centers
- **CNC Wire EDM**: Wire electrical discharge machining for intricate cuts and hard materials. URL: https://www.primomedicalgroup.com/cnc-machining/cnc-wire-edm
- **CNC Turning**: Precision CNC turning for cylindrical and rotational components. URL: https://www.primomedicalgroup.com/cnc-machining/cnc-turning

### Secondary Operations
URL: https://www.primomedicalgroup.com/secondary-operations

Primo provides a full range of secondary operations to support complete part finishing and processing without requiring additional outside vendors.

- **Tube Bending**: Precision tube bending for medical and industrial components. URL: https://www.primomedicalgroup.com/secondary-operations/tube-bending
- **Deburring**: Removal of sharp edges and burrs from machined components. URL: https://www.primomedicalgroup.com/secondary-operations/deburring
- **Grinding**: Precision surface and cylindrical grinding for tight tolerance finishing. URL: https://www.primomedicalgroup.com/secondary-operations/grinding
- **Sandblasting**: Surface preparation and finishing via sandblasting. URL: https://www.primomedicalgroup.com/secondary-operations/sandblasting
- **Ultrasonic Washing and Degreasing**: Precision cleaning of components using ultrasonic processes. URL: https://www.primomedicalgroup.com/secondary-operations/ultrasonic-washing-and-degreasing
- **Laser Marking and Welding**: Permanent laser marking for traceability and UDI compliance, plus laser welding for precision joining. URL: https://www.primomedicalgroup.com/secondary-operations/laser-marking-and-welding

## Materials

Primo Medical Group works with a range of medical-grade metals and engineered plastics for medical, aerospace, and defense applications.
URL: https://www.primomedicalgroup.com/materials-we-work-with

- **Plastics**: Medical-grade engineered plastics for device components and assemblies. URL: https://www.primomedicalgroup.com/materials-we-work-with/plastics
- **Cobalt Chrome**: High-strength, biocompatible cobalt chrome alloys for implant and surgical instrument applications. URL: https://www.primomedicalgroup.com/materials-we-work-with/cobalt-chrome
- **Titanium**: Lightweight, biocompatible titanium alloys for implants, surgical instruments, and aerospace components. URL: https://www.primomedicalgroup.com/titanium
- **Stainless Steels**: Medical and surgical grade stainless steels for instruments, housings, and structural components. URL: https://www.primomedicalgroup.com/materials-we-work-with/stainless-steels
- **Inconel**: High-temperature, corrosion-resistant nickel superalloys for demanding aerospace and defense applications. URL: https://www.primomedicalgroup.com/materials-we-work-with/inconel
- **Tungsten**: High-density tungsten for radiation shielding, counterweights, and precision components. URL: https://www.primomedicalgroup.com/tungsten

## Services

URL: https://www.primomedicalgroup.com/services

Primo Medical Group offers a full suite of engineering, program management, and supply chain services to support customers across the product lifecycle.

- **Early-Stage Development**: Engineering and manufacturing support for products in early development, including design for manufacturability and prototype production. URL: https://www.primomedicalgroup.com/services/early_stage_development.asp
- **Design and Development**: Collaborative design and development services for medical device components and systems. URL: https://www.primomedicalgroup.com/services/design_and_development.asp
- **Project Management**: Structured project management to ensure on-time delivery, quality, and cost control across complex manufacturing programs. URL: https://www.primomedicalgroup.com/services/project_management.asp
- **Supply Chain Management**: Integrated supply chain solutions to manage sourcing, procurement, and vendor coordination for complex production requirements. URL: https://www.primomedicalgroup.com/services/supply_chain_management.asp
- **Warehouse and Logistics**: Warehousing and logistics support integrated with manufacturing operations. URL: https://www.primomedicalgroup.com/services/warehousing_logistics.asp
- **Fulfillment Services**: Finished goods fulfillment services for distribution of completed medical devices and components. URL: https://www.primomedicalgroup.com/services/fulfillment-services

## Industries Served

URL: https://www.primomedicalgroup.com/industries-served

- **Medical Implants**: Precision manufacturing of implantable device components in biocompatible materials including titanium, cobalt chrome, and stainless steel. URL: https://www.primomedicalgroup.com/industries-served/medical-implants
- **Medical Tools and Surgical Instruments**: Contract manufacturing of surgical instruments and medical tools to OEM specifications. URL: https://www.primomedicalgroup.com/industries-served/medical-tools-and-surgical-instruments
- **Robotic Surgery**: Precision components and assemblies for robotic surgical systems requiring extreme accuracy and reliability. URL: https://www.primomedicalgroup.com/industries-served/robotic-surgery
- **Electromechanical Medical Systems**: Design and manufacturing of electromechanical assemblies for medical devices and systems. URL: https://www.primomedicalgroup.com/industries-served/electromechanical-medical-systems
- **Surgical Instrument Reprocessing**: Refurbishment and reprocessing services for surgical instruments. URL: https://www.primomedicalgroup.com/industries-served/surgical-instrument-reprocessing
- **Aerospace and Defense**: Precision machined components and assemblies for aerospace and defense applications, manufactured under ITAR compliance. URL: https://www.primomedicalgroup.com/industries-served/aerospace-and-defense
- **Custom Commercial Markets**: Precision manufacturing for demanding commercial applications outside core medical and defense markets. URL: https://www.primomedicalgroup.com/industries-served/custom-commercial-markets

## Quality and Regulatory

URL: https://www.primomedicalgroup.com/services/quality_regulatory.asp

Primo Medical Group maintains a comprehensive quality management system and holds certifications required for medical, aerospace, and defense manufacturing.

- **Quality Philosophy**: Commitment to continuous improvement and zero-defect manufacturing. URL: https://www.primomedicalgroup.com/about/quality_philosophy.asp
- **ISO 13485:2016**: Medical device quality management system certification. URL: https://www.primomedicalgroup.com/about/iso9000.asp
- **FDA Registration**: FDA-registered manufacturing facility for medical device production. URL: https://www.primomedicalgroup.com/about/fda_info.asp
- **ITAR Compliance**: International Traffic in Arms Regulations compliance for defense-related manufacturing. URL: https://www.primomedicalgroup.com/about/itar.asp
- **Continuous Improvement**: Six Sigma and structured continuous improvement methodologies embedded in manufacturing operations. URL: https://www.primomedicalgroup.com/about/continuous_improvement.asp
- **Six Sigma**: Application of Six Sigma tools and methods to reduce variation and improve quality. URL: https://www.primomedicalgroup.com/about/six_sigma.asp
- **Other Registrations and Compliance**: Additional certifications and compliance documentation. URL: https://www.primomedicalgroup.com/quality-and-regulatory/other-registrations-and-compliance
- **Quality and Regulatory Consulting Services**: Consulting services for quality and regulatory compliance. URL: https://www.primomedicalgroup.com/quality-and-regulatory/quality-and-regulatory-consulting-services

## Corporate Network and Innovation

Primo Medical Group supports innovation in the medical device industry through its corporate network and innovation center, having incubated and co-funded eight companies.

URL: https://www.primomedicalgroup.com/about-us/corporate-network

- **MarverMed**: https://www.primomedicalgroup.com/corporate_network/marver_med.asp
- **Sync Medical**: https://www.primomedicalgroup.com/corporate_network/sync_medical.asp
- **Trax Surgical**: https://www.primomedicalgroup.com/about-us/corporate-network/trax-surgical
- **Arthrosurface**: https://www.primomedicalgroup.com/about-us/corporate-network/arthrosurface
- **Innovation Center**: Dedicated facility and resources for developing next-generation medical technologies. URL: https://www.primomedicalgroup.com/corporate_network/innovation_center.asp
- **Start-Up Companies**: Program supporting medical device startups with manufacturing expertise, engineering resources, and co-funding. URL: https://www.primomedicalgroup.com/corporate_network/startup_companies.asp

## Scope and Capabilities

- Primo Medical Group is a contract manufacturer — not a medical device brand or OEM. The company manufactures to customer specifications and supports customers' regulatory submissions.
- Primo supports both prototype/development quantities and high-volume production runs.
- Vertically integrated capabilities across five Massachusetts facilities allow Primo to manage multiple production stages internally, reducing supply chain complexity for customers.
- Primo supports full lifecycle manufacturing from early-stage development and design through production, assembly, and distribution fulfillment.
- ITAR compliance enables Primo to support defense and government-related manufacturing programs.
- Quality and regulatory consulting services are available for customers navigating FDA, ISO, or compliance requirements.

## Resources and Content Types

- **Equipment List**: Comprehensive list of manufacturing equipment across Primo's facilities. URL: https://www.primomedicalgroup.com/equipment-list
- **Materials Pages**: Detailed pages for each material Primo works with, including specifications and application context. URL: https://www.primomedicalgroup.com/materials-we-work-with
- **Request for Quote**: RFQ submission for contract manufacturing inquiries. URL: https://www.primomedicalgroup.com/request-quote
- **Company History**: Timeline of Primo Medical Group's development since 1953. URL: https://www.primomedicalgroup.com/about/company_history.asp
- **Press and Videos**: Press releases and video content. URL: https://www.primomedicalgroup.com/about/press_and_videos.asp
- **Events**: Trade shows and events where Primo Medical Group exhibits. URL: https://www.primomedicalgroup.com/about/events
- **Careers**: Employment opportunities at Primo Medical Group. URL: https://www.primomedicalgroup.com/careers
- **Contact**: Direct contact for manufacturing inquiries. URL: https://www.primomedicalgroup.com/contact.asp
- **Privacy Policy**: https://www.primomedicalgroup.com/privacy-policy
- **Sitemap**: https://www.primomedicalgroup.com/sitemap

## Key Facts

- Founded: 1953
- Headquarters: 75 Mill Street, Stoughton, MA 02072
- Phone: 781-828-4400
- Website: https://www.primomedicalgroup.com
- Facilities: Five locations in New England, Massachusetts
- Certifications: ISO 13485:2016, FDA Registered, ITAR Compliant
- Specialization: Full-service contract manufacturing for medical, aerospace, and defense industries
- Core Capabilities: Catheter and endoscopic device manufacturing, precision CNC machining, ISO Class 7 cleanroom assembly, secondary operations, supply chain management, fulfillment
- CNC Machining Methods: CNC milling, CNC turning, CNC laser Swiss machining, 5 & 7 axis machining, CNC wire EDM
- Secondary Operations: Tube bending, deburring, grinding, sandblasting, ultrasonic washing and degreasing, laser marking and welding
- Materials: Titanium, cobalt chrome, stainless steel, Inconel, tungsten, medical-grade plastics
- Industries Served: Medical implants, surgical instruments, robotic surgery, electromechanical medical systems, surgical instrument reprocessing, aerospace and defense, custom commercial markets
- Corporate Network: Innovation center and startup incubation; co-funded eight companies
- Quality Methodology: Six Sigma, continuous improvement, ISO 13485 QMS
- Primary Use Cases: Medical device contract manufacturing, catheter and endoscopic device production, precision CNC machined medical components, cleanroom assembly, aerospace and defense precision parts