QUALITY, EFFICIENT
& COLLABORATION
OUR SERVICE FRAMEWORK IN A NUTSHELL
Product Development Lifecycle
Clinical
Affairs
Proof of Concept
Design and Development
Pre-Clinical Validation Planning and Execution
Verification Planning and Execution
Clinical Validation Planning and Execution
Design Transfer
Mass Production
Regulatory Affairs
Quality Management
Regulatory Strategy
Submission
Preparation
Clearance or Approval (Product Launch)
QMS Establishment
QMS Maintenance
Design & Development
▰ Experienced engineering and software development team developing engineering prototypes
▰ Dedicated resources to assist your product verification and validation activities
▰ Open-source software partners to support your product and engineering development needs by utilizing existing OTS to advance your product iterations with speed and precision
▰ Potential partnerships with Taiwan and China-based hospital systems to establish clinical validations throughout the product development lifecycle
▰ Experienced designers and engineers to develop solutions in an iterative fashion to meet your goals of device aesthetic, performance and safety testing, usability, manufacturability, and quality assurance
▰ Skillful software development team to help your proof-of-concept software version with the intention to allow scalability and feature enhancement throughout the software device lifecycle
Quality Management
▰ Knowledgeable quality team to support seamless transition from engineering and product development activities to quality and regulatory activities
▰ All the quality and regulatory activities will be compliance with ISO 13485 and FDA QSR
Regulatory Affairs
▰ US and APAC regulatory experts that can help you distill market opportunities in both regions and develop regulatory strategies
▰ Our innovation partners (e.g., venture, clinical, business development…etc) in the US and APAC can support your go-to-market strategies
Clinical Affairs
▰ Dedicated research team to assist pre-clinical and clinical validation planning, preparation, and execution.
▰ Scientific liaison to effectively communicate the validation requirements between manufacturer and the Principle Investigators/IRB Committee/CRO Organizations
Manufacturing Scale-up
▰ Well-versed contract manufacturing team with mass production experience of consumables, capital equipment, intravascular devices...etc.
▰ Taiwan and APAC-based contract manufacturing partners dedicated to meet your volumeproduction needs
▰ Serve as engineering and quality liaison between your organization and your partners
▰ Expert software development team can continuously support your software device iteration and maintenance needs throughout the device lifecycle
