Paradyne Medical
Paradyne Medical is a full-service medical device manufacturer specializing in turn-key engineering and manufacturing solutions for the medical, biomedical, and life science industries. They offer comprehensive services including concept design, engineering, manufacturing, and supply chain management, with a focus on quality, reliability, and regulatory compliance. Their mission is to be a strategic partner providing high-quality manufacturing solutions, ensuring product safety and effectiveness, and supporting clients from startups to established OEMs.
Industries
Nr. of Employees
small (1-50)
Paradyne Medical
Services
Concept generation, feasibility, prototype fabrication, product design, process development, verification and validation through manufacturing transfer.
Production of sterile and non-sterile medical devices in HEPA-filtered ISO-certified cleanrooms, including assembly, kitting and packaging.
Design and production of catheters and medical balloons with multiple materials and configurations, including drug-eluting and multi-balloon designs.
Custom manufacturing of ePTFE tubes and sheets for medical applications requiring microporous membranes and biocompatibility.
RF welding, ultrasonic welding and laser cutting/welding for joining plastic components and assemblies.
Implementation and maintenance of ISO 13485-compliant QMS, design control, document control, supplier management, risk management (ISO 14971) and regulatory submission support.
Concept generation, feasibility, prototype fabrication, product design, process development, verification and validation through manufacturing transfer.
Production of sterile and non-sterile medical devices in HEPA-filtered ISO-certified cleanrooms, including assembly, kitting and packaging.
Design and production of catheters and medical balloons with multiple materials and configurations, including drug-eluting and multi-balloon designs.
Custom manufacturing of ePTFE tubes and sheets for medical applications requiring microporous membranes and biocompatibility.
RF welding, ultrasonic welding and laser cutting/welding for joining plastic components and assemblies.
Implementation and maintenance of ISO 13485-compliant QMS, design control, document control, supplier management, risk management (ISO 14971) and regulatory submission support.
Expertise Areas
- Medical device design and development
- Catheter and balloon systems
- Turnkey medical device manufacturing
- Supply chain and procurement for medical devices
Key Technologies
- ePTFE sintering and microporous membrane processing
- Radio-frequency (RF) welding
- Ultrasonic welding
- Laser cutting and welding