Service
New Product Development (NPD) for Medical Devices
Bringing a medical device to the market requires a structured development process that meets global regulatory compliance and industry standards. UpShot provides expert driven product development services to help manufacturers achieve faster approvals while ensuring safety and efficiency at every stage.
Comprehensive Medical Device Design & Development
Our New Product Development (NPD) services cover end-to-end support, design, verification, and validation, design transfer ensuring compliance with FDA, EU MDR, NMPA and ISO 13485 standards. Whether you’re an established manufacturer or a MedTech startup, our team ensures your device is designed, tested, and documented to meet global regulatory requirements.
Our Key NPD Services
Design Conceptualization & Requirement Traceability Matrix
Support in early-stage concept development, CAD modeling, and drafting. We also create a traceability matrix to map design inputs to DHF deliverables, ensuring complete compliance with regulatory documentation requirements.
Design Input Requirements Development
Assist in capturing the Voice of Customer (VOC) and translating it into measurable, testable design input requirements—enabling effective design qualification and regulatory compliance.
Risk Analysis
Identify and mitigate potential risks related to design and manufacturing. Maintain and update risk management documentation at each stage of the NPD cycle in alignment with ISO 14971.
GD&T and Tolerance Stack-Up Analysis
Perform Geometric Dimensioning & Tolerancing and tolerance stack-up studies to ensure precise engineering and robust device performance.
Design Verification & Validation
Develop verification plans/protocols that align with design inputs, validated test methods, and statistical sampling plans.
Coordinate testing activities with internal teams or third-party labs, collect raw data, and generate statistically sound DV reports.
Support design validation planning and reporting, including simulated use testing with clinicians or labs as required.
Design Transfer to Manufacturing
Ensure smooth transition from R&D to manufacturing by supporting process qualification and validation. Transfer all finalized design documentation and ensure readiness for scalable, compliant production.
Usability Engineering
Evaluate human factors and use scenarios to enhance user safety and device effectiveness. Provide support for usability engineering planning and reporting per IEC 62366-1 standards
Biocompatibility Assessment
Support material selection and testing processes to ensure patient safety in accordance with ISO 10993. Assist in preparing biocompatibility reports and coordinating testing as needed
Why Choose UpShot Engineering?
Several modules that can be used separately or together to adapt to your reality
Accelerated Compliance
Get your medical device approved faster with our structured regulatory approach.
End-to-End Support
From design planning to post-market surveillance, we cover every compliance milestone.
Industry Expertise
Our team brings years of experience in medical device design and validation.
