
- Medicine and Healthcare
Machine Solutions ISO 9001 Documentation
Background
Machine Solutions provides comprehensive solutions for medical device manufacturers and is a holistic supplier for the medical device, catheter, and stent manufacturing space. The company’s goal is to “deliver innovative and tailored solutions that enhance product quality, streamline manufacturing processes, and ultimately reduce costs for our customers.”
The Challenge
Machine Solutions needed new product development (NPD) processes and documentation developed to meet ISO 9001 requirements, a globally recognized standard for quality management.
The Process
Nova Arc’s writing and editing teams met biweekly with product development engineers at Machine Solutions, gathered documentation, and recorded interviews with NPD engineers.
The Results
Nova Arc delivered a professionally designed, written, and edited ISO 9001-compliant NPD documented process, including a flowchart for easier use and improved adherence to process.
Client Feedback
“I really appreciated how easy the Nova Arc team is to work with. They asked questions when they did not understand and asked clarifications when something did not align with what we had talked about. Responses via email were quick and to the point. Meetings were also good for alignment and check-ins on progress.” — Ariana, Machine Solutions

