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The Second Pillar of Medical Device Engineering: Creating an Effective Quality System

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In our last blog, we explored Design Control – the first of three pillars that support quality medical device development. The second pillar is the creation of a Quality System.

This pillar is instrumental in meeting regulatory requirements to FDA and CE Mark agencies requiring compliance to ISO 13485 – Medical Devices Quality Management System and ISO 9001 – Quality Management System.

Regulatory entities require that the framework of a quality system be compliant to the governing standards within their jurisdiction. For those clients that do not have an established quality system, REV.1 Engineering can provide that entire package compliant to global governing standards, along with a cloud based Quality System Electronic Database.

Here’s what you should look for when shopping for a turnkey quality system:

  • Electronic database with team access that is compliant to 21CFR part 11 (traceability of electronic signatures)
  • Sufficient storage for all drawings, SOPs, and manufacturing details
  • Detailed tracking of users as they work on stored documents (revision control)
  • Ability to easily access past SOP revisions
  • Employee training and training documentation
  • Provide SOPs that carry the developed product through the design transfer phase into manufacturing
  • Ability to customize to the needs of your product
  • Ability to customize with your logo and branding

A customized quality system must be comprehensive and flexible, but foremost be compliant to all regulatory governing standards.

Regulatory agencies also require that training be documented. Whoever will work in the system must be trained… and in order for the quality system to work best, everyone should work within the system: engineers, technicians, executives, and manufacturing staff. A good quality system will track all employee access, requiring and saving their acknowledgment of the training, and monitoring and keeping all changes each employee makes to design documents.

If you are looking for an effective customized quality system, REV.1 Engineering can help. Join companies like Zeavision, NAI and Nocira that have worked with us to successfully implement a quality system. Give us a call at 951.696.3933, connect with us on LinkedIn, or send us an email at, and let’s create a quality system to get your medical device to FDA approval – 2x Faster.