Quality & Regulatory Compliance
With 50+ years of medical device experience, we have developed a thorough understanding of the complex regulatory environment. Every product is manufactured to exact specification, in full compliance with FDA guidelines, at one of our ISO-certified facilities. We host 100+ audits per year from customers and regulatory bodies.
Our certifications and registrations:
- ISO 13485 and 14971 Risk Management Certified
- FDA Registered and compliant with the Quality System Regulation
- Class I, II, and III medical devices, including Premarket Approval (PMA) products
- Class 7 and Class 8 Cleanroom Controlled Environments
- US FDA 21 CFR Part 820 compliance
- Canadian Medical Device Conformity Assessment System compliance
- Medical Device Single Audit Program (MDSAP)
Global Quality Systems
Our enterprise-wide quality policy and program are designed to ensure consistent high quality and compliance at every location, on every project, at every stage of the product lifecycle. Dedicated on-site teams ensure compliance with rigorous internal quality systems, some of which include:
- Supplier management
- Internal audit processes
- Validation strategy
- Design controls
- DHF-ready documentation
Nordson's Progress with PFAs
The Nordson Corporate Product Compliance Department is diligently monitoring the growing global requirements surrounding Per- and Poly- Fluoroalkyl Substances (PFAS). We are working with all Nordson divisions to determine where PFAS are currently being used, and to identify our risks moving forward. These risks include current and potential restrictions and notification requirements, customer requirements, and supply chain disruptions due to supplier phase out of PFAS containing materials. Our goal is to meet all of our legal requirements while minimizing the impact on our customers.
