Quality

Quality is first in everything we do

JunoPacific is committed to exceeding our customers’ expectations. In keeping with this commitment, JunoPacific has developed and implemented a Quality Management System (QMS) conforming to the exacting standards expected by today’s medical device industry. Our QMS assures the highest quality products and services that meet and exceed your requirements by using advanced metrology and analytical techniques. When combined with robust training and continual management review, you can be assured that you are working with the most highly skilled people in the industry, using the best technology available.

Our QMS reflects the requirements of the FDA’s 21 CFR Part 820 quality systems regulation and is certified under ISO 13485:2016.

Quality Systems Certifications

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EN ISO 13485:2016

ISO 9001:2008

FDA Registration as a Contract Manufacturer

State of California – Department of Public Health and Food and Drug Branch – Device Manufacturing License #59603

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Quality Engineering

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At the beginning of every new project, we work together with our customers to assure that quality is built into the products in the design stages. We accomplish this through our Stage Gate process with deliverables that include:

  • Advanced planning quality planning (APQP)
  • Failure Mode and Effects Analysis (FMEA)
  • Statistical Process Control (SPC)
  • Measurements System Analysis (MSA)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Production Qualification (PQ)

We ensure that our processes have the documentation and traceability to meet the current medical device industry standards and practices.

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Quality Assurance

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JunoPacific is committed to exceeding our customers’ expectations. In keeping with this commitment, JunoPacific has developed and implemented a Quality Management System (QMS) that conforms to the exacting standards expected by today’s medical device industry. Our QMS assures the highest-quality products and services to meet your requirements by using advanced metrology and measurement techniques. Not only does this help ensure conformance with each specification, but it supports the continuous improvement process as well. Combine this with a robust training program and you can be assured that you are working with the highly skilled people in the industry, using the best technology available.

Our quality system reflects the requirements of the FDA’s 21 CFR Part 820 quality systems regulation.

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