Capabilities
Design
Paradyne Medical's skilled designers bring decades of experience in the medical device industry. Complete services include the design and rendering of equipment, fixtures and components at multiple levels - from concept to prototypes to fully commercialized products.
Quality Control
We are an FDA registered, ISO 13485 certified medical device manufacturer of sterile and non-sterile devices. We utilize a state of the art TQM system and continuous improvement to keep our customers in compliance with all regulations.
Manufacturing
Operating in our state of the art, HEPA filtered, ISO certified cleanroom, Paradyne Medical provides full turnkey services including manufacturing, engineering, sterilization and validation.
Supply Chain Management
Paradyne Medical understands that one of the keys to success for any product is having a robust supply chain that offers end-to-end supply chain management including procurement, inventory management, and fulfillment.
Technical Specialties Include:
Custom Equipment/Tool Design and Fabrication
Electronics design and assembly
Stent encapsulation
Catheter and balloon fabrication
Medical Device Assembly, Kitting and Packaging
Additional services available.
Product Development Services
Paradyne Medical offers the following Design and Development services to facilitate your new product market launch:
- Early-stage feasibility studies, including design and fabrication of models
- Product design
- Prototype fabrication and testing
- Development of product specifications
- Design verification, including development of test protocols and testing
- Tooling, equipment and fixture design and fabrication
- Process development and validation, including documentation and testing
- Packaging design and validation support
- Sterile validation support
- Component and raw material selection and sourcing
- Design history file
- Biocompatibility testing support
- Regulatory support; 510(k), CE Mark, PMA
- Manufacturing
- Technology Transfer
Developmental Product Testing
Paradyne Medical offers a full range of compliance and performance testing capabilities to fully support the development of catheter-based systems and medical devices. Whenever applicable, our test protocols incorporate the latest ISO standards. Product testing services include:
- Test protocol and custom test method development
- Tensile testing
- Leak and pressure testing
- Dimensional testing
- Performance testing