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Author: Anne Holland, CEO and Founder

As a busy medical device startup leader, you already know that you need a quality system in place to bring your new product to market safely and efficiently.

What you may not be as familiar with are the various elements that comprise a successful quality system. That’s why our team of quality engineering experts have compiled:

Seven Quality System Must-Haves: 
  1. Design Controls
  2. Design and Development Planning
  3. Documentation and Record Controls
  4. Purchasing Controls
  5. Supplier Qualification
  6. Risk Management
  7. Design Transfer and Process Validation

Does your quality system have all of these? Download the medical device quality system checklist now.

Start Early to Avoid the Costs of Poor Quality

McKinsey & Company estimates the direct cost of poor quality in the medical device industry is $26 – $36 billion annually.

Developing a quality system early in a project reduces the risks associated with bringing your product to market and saves you from a significant hit to your bottom line due to the unexpected costs of poor quality.

Quality is the foundation of a successful medical device product launch that you can’t afford to put off.

Lean Into Our Medical Device Startup Expertise

This valuable quality systems checklist is just the start of your quality journey.

Learn more about what you need to make the medical device startup process a success and download our latest white paper that includes the seven must-haves, The MedTech Startup Guide to Quality.

We’ve been providing medical device quality consulting services to startups for more than 20 years – we can help.

Let’s get the quality conversation started