Part 2 – Quality System Development for Start-ups

Engineering & Quality Solutions, Inc. is the perfect resource for medical device start-ups and business ventures. Contact us today to get started.

Part 2 – Quality System Development

This is the second installment in a four-part series on how Engineering & Quality Solutions, Inc. can help business ventures and start-ups by consulting on product development, quality systems, manufacturing and transitioning to internal resources if needed. We consult on-site or remotely and can work in a small or large capacity, as company inside resources or outside consultants, whatever works for your company model and stage. Many start-ups operate entirely in the cloud with resources living in different states, and this is a great model to reduce overhead and attract the best personnel. As the company and business evolves and grows, we adapt and provide the resources you need at the exact time you need them!

Once a medical device start-up has completed the concept and is conducting final product development, it’s time to start implementing a quality system. This will help ensure activities are completed in compliance with FDA 21 CFR 820 and the company is poised to move to manufacturing and distribution as soon as possible. The consultants at Engineering & Quality Solutions, Inc. have developed, implemented, and streamlined dozens of quality management systems for start-ups. We know the regulations and we have worked in the trenches ourselves, so we can implement a system which is compliant and functional without being cumbersome. We’ve also been through many FDA inspections and helped companies recover from FDA warning letters.

We can help with:

• Developing a Complete Quality System
• Updating, Finishing or Streamlining an Existing Quality System
• Conducting Internal Audits
• Maintaining QMS Records
• Acting as Quality Manager
• Preparation and Representation for FDA Inspections