Process capability and documentation
Pulse Technologies is a quality engineer’s best friend. Long before we invested in the newest equipment or the greatest facility, we began by building quality into everything we do.
Process planning for quality
Quality can never be an accident. At Pulse, quality is the result of intentional, concentrated focus on the processes that ensure a consistent, to-the-spec production. Our long experience in the medical device industry means an intimate understanding of the safety and regulatory requirements for implantable devices. Our people, processes and technologies all support those mandates.
Read more about our quality capabilities.
“We engage in a continuous review of processes to find efficiencies, validated against best practices and shared with our partners.”
We are ISO 9001:2008 (download PDF), ISO 13485:2003 certified (download PDF) and Compliant to 21 CFR Part 820. Our components shipments include Certificates of Compliance and Material. We can also provide First Article Reports, SPC Production Reports, and any specialized testing results required.
Attention to detail
We also deliver:
- Real-time statistical process control at the machines to save time and cut waste
- Dock to stock, Kanban and consignment arrangements with major device makers
- Rapid response to quality issues
- Consistency from prototype to production
- A full suite of metrology gauges, tools, fixtures and equipment (read more about our metallurgy and metrology lab)
Are you a Quality Engineer? What else do you want? Tell us how we can help: