Our New Product Introduction (NPI) team is focused on ensuring a seamless transition from design to manufacturing. Each of our design and development facilities and our commercial production sites have dedicated NPI specialists and technicians who identify risk, analyze feasibility, develop sustainable processes, and manage the successful pilot manufacturing and launch of complex medical devices.
Testing & Validation
Our NPI and engineering teams can work with you on all testing and validation requirements:
- Equipment IQ/OQ/PQ
- Process Specifications
- PPQ/Process Validation
- Statistical Process Control
- Test Method Validation
- Component Qualification
- Design Transfer
Quality & Regulatory Support
Our dedicated quality team of 50+ quality engineers and technicians can work with you to:
- Support your existing quality system with audit-ready documentation
- Create and manage your design history file and design controls within the Nordson MEDICAL quality system
- Design and map a hybrid quality system
- Create new quality management systems for startup companies
Our quality system services include:
- Full documentation, including design document control, risk management files, design history files, device master records, and quality system guidance documents
- Technical support and documentation preparation for regulatory submission packages, including premarket approval documents and package filing support
Certifications, registrations, and compliance include:
- ISO 13485:2016 Certified
- ISO 14971:2007 and EN ISO 14971:2010 Certified for Risk Management
- Compliance with FDA 21 CFR Part 820
- Class 7 & 8 cleanroom facilities co-located with the development team
- Customer and FDA audits
3P Production Planning Services
Our 3P (Production. Process. Preparation.) Service can minimize waste by evaluating the true requirements and function of a product design or process. Our team can conduct a thorough review and recommend opportunities to refine your process, products, and/or parts. The result of the 3P method can be a breakthrough concept.
Why 3P?
- Waste Elimination
- Zero Based Budgeting (of the design)
- Cost Management
- Quality Management
- Drives Continuous Improvement
- Improves Capabilities of an Organization
