Medical Materials and Technology - Composite Sealing Systems Division | Parker US
health care workers performing a surgical procedure on a patient

Parker is FDA registered and an ISO 13485 certified contract manufacturer of precision components and finished medical devices. Utilizing today's validated medical grade materials and advanced technology processes, we work with medical device companies around the world to deliver products that improve patient outcomes.

 

Leverage Advantages that Streamline Your Product Launch

 

Global Footprint, Local Support

Engineering, Process Development, Tooling Management

No matter where you choose to manufacture and distribute your product, Parker can support your strategy through the entire process with:
 

Design for Manufacture, Assembly and Value Added Services
Parker teams have advanced skills in manufacturability analysis, material selection, functional analysis using Finite Element Analysis (FEA), rapid prototyping, sterilization vendor management, sterile package design, shipping box design and configuration, logistics, and distribution.

Tooling Management
Our complete program management includes in-house engineering and working with local and global tooling vendors for all aspects of design, mold flow analysis, prototype, production, and tool maintenance.  

Process Development & Validation
Capabilities span assembly and test process definition & design, tooling and fixture design and fabrication, equipment validations including I/Q, O/Q & P/Q, validation protocol development, accelerated age studies, transit testing, biocompatibility testing.

engineer seated at computer desk in medical manufacturing environment

 

Strategic Partnerships for Life Sciences

In collaborating with OEMs throughout the entire product lifecycle, we work to ensure our customers' return on investment and drive advancements in the life sciences industry.  

 

 

Medical and Life Sciences Capabilities

See some of the manufacturing, processing and technology capabilities at Parker CSS Division for medical device and life science OEMs. We bring success to our customers by working together through all phases of design for manufacturing, quality control, inspection, and secondary operations to quickly deliver new products to market.
 

Click the image to watch the video.

video highlights of life science design, engineering, and manufacturing expertise
worker in medical device manufacturing facility performing quality check on product component

Concept & Feasibility

Collaborative Engineering | Eliminating Development Risk Factors

Parker works as a valuable source of innovation, using our engineering, manufacturing and quality planning expertise to critically evaluate design concepts for optimal manufacturability and functional performance.

Early supplier involvement with our customers allows

  • Upfront discovery of potential design discrepancies and supply chain constraints
  • Assurance that production will meet feasibility requirements
  • Certainty of compliance with regulations governing production

two people in medical device manufacturing tool room

Design for Manufacturing

DFMA | Rapid Prototyping | Validation 

In working alongside our customers during their product development, we can deliver extra value in the areas of 

  • Design for manufacturing and assembly (DFMA)
  • Evaluation of methods of manufacture 
  • Prototyping
  • Data validation
  • Documentation

worker in ISO13485 site cleanroom performing quality inspection

Process Development

Comprehensive Planning

As a process driven, lean enterprise, Parker thoroughly vets all processes necessary to achieve smooth transition from concept to production, incuding

  • Assembly and test process definition
  • Tooling and fixture design, and fabrication
  • Equipment validations including I/Q, O/Q & P/Q
  • Validation protocol development
  • Accelerated age studies, transit and biocompatibility testing

photograph of molded and extruded silicone medical devices and components

Production & Launch

Release Plan | MRP | Quality

By using productivity metrics and maintaining uncompromising quality control, we ensure that our solutions match customers expectations. We continue to work through the entire product lifecycle with sustaining improvements to ensure our customers' return on investment.

Medical Manufacturing Process Capabilities

Volume, Material & Method of Manufacture Flexibility

Our capabilities include diverse manufacturing processes that accommodate flexibility on volumes, and the ability to optimize materials to meet specific needs. Learn about our expertise with

  • Thermoset and thermoplastic elastomer molding
  • Liquid injection molding (LIM) of liquid silicone rubber (LSR)
  • Silicone extrusions
photograph of clean room manufacturing production floor for LSR medical devices and components

Medical Materials Expertise

USP Class VI Formulations

For healthcare and life science applications, we offer biomedical and pharmaceutical OEMs a wide range of medical grade materials that meet USP Class VI requirements for biocompatibility, including:

  • Thermoplastics
  • Elastomers
  • Silicones
  • USP <381> Compliant Polyisoprenes
graphic of molecules and molecular structure models

Value Added Services

Cost Effective Streamlining

We offer services that allow customers to streamline manufacturability, quality, cost-effectiveness and overall product-to-market timeline of newly designed components and devices.  Services include:

  • Assembly, kitting and packaging
  • Forming and joining
  • Surface treatments and imaging
  • Metrology and testing
  • Complete tooling management
  • Sterilization consultation and management
  • Logistics management

Why Parker?

Focus on Quality

We provide products and services that consistently meet customer expectations of quality and value. A central element of our culture is an unwavering commitment to quality and continuous improvement. 

photograph of worker viewing magnification of medical device tooling component
medical worker holding clamps and threaded suture and suture needle

Ready to begin?