PendraCare has an expert R&D team with many years experience at world leading medical device companies.
The team has the competencies and technologies to handle the full development cycle from concept development to manufacturing, including steps like
- Rapid concept and prototype development
- Materials selection and sourcing
- Design control:
- Risk Management: Application-, Design- and Process FMEA's
- Design Validation & Verification
- Validations Process Validation (Equipment, Test Methods, Process, Product)
- Validated Test Methods
- Pilot plant development
In addition to technological experience, the team has extensive design control experience and in-depth understanding of Medical Device regulations.
OEM products developed and manufactured by PendraCare’s R&D team for own production and third parties include diagnostic and guiding catheters, PTA & PTCA balloon catheters to stent delivery systems, urology catheters and gastroenterology catheters. These products are sold globally by major medical devices companies and distributors.