Get an ISO 13485 audit quote in minutes — no obligations!
Professional, local auditors experienced in your industry,
and at a price you can afford.

“We have engaged Quality Auditing LLC for 3 consecutive years, auditing to ISO 13485. The two auditors they’ve sent have excellent credentials and are very knowledgeable of the standard applying it fairly and pragmatically. Registrar auditors have often commented positively as to the quality and content of the internal audit performed. We shall be engaging them again next year."

— M. Truman, QA Director

How it works:

“We are a manufacturer out here in Chatsworth, California. We make medical device components for our customers under the ISO 13485:2016 standards. QA’s Lead Auditor was very nice, professional and very thorough and was "on the ball". She spotted the "grey" areas that were previously missed. Kudos to Quality Auditing. I'm looking forward to working with them again next year.”

— John B., QA Manager

We make it easy for you.

We understand the importance of industry knowledge—it’s the heart of our business. Our deep experience working across different sectors, standards, and regulations enable us to understand your challenges in the compliance landscape but also provide strategic insights and current market intelligence to help you achieve excellence.

How do I get started?

Simply click the button below, fill out the quick form and we’ll get in touch ASAP to get you a quote.

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You run your business.
We do your ISO 13485 auditing.

The Gold Standard of Auditing

Or Give us a call: (612) 208-7845

You’re a busy professional with lots to do. We’re professional ISO 13485 auditors with experience performing thousands of audits for the Medical Device Industry.

Let us take auditing off your hands forever — so you can focus on what matters most.

We work with companies big & small.
We can help you too.

We’ve honed our expertise working with organizations that range from globally recognized brands to small, family-owned companies in more than 25 countries. Start-ups and established multinationals choose Quality Auditing as their partner to achieve and maintain compliance with global standards & regulations. This positions us to provide unique insights that you can’t find anywhere else.

1. Get a quote

2. Schedule your audit

3. We audit for you

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Frequently Asked Questions

Or Give us a call: (612) 208-7845

How are your auditors trained?

Our Medical Device Auditors all have experience in the industry and maintain credentials for ISO 13485:2016 and country-specific regulations. Resumes and credentials are provided as part of the quotation package.

Do you have local and/or worldwide auditors?

Yes! We have many auditors in most major cities across the US as well as Central & South America, Europe, Middle East, South & East Asia. We have auditors that are well versed & seasoned in each industry that we serve.

How much is it going to cost?

Our flat-rate pricing ensures budgeting is easy and you can be assured there will never be additional or unexpected fees. It’s always fair & transparent. 

When can you perform the work?

Typically 6 weeks or less. Audits of a longer nature may require some additional time to schedule.

What does the report look like?

We have fantastic reporting. Let us know if you'd like to see one and we'll show you. We are also happy to customize our report format to meet your needs, or work with something you already have established.

How soon can we start?

Right away! Fill out the form on this page or give us a call at (612) 208-7845

You run your business. We’ll do your ISO 13485 audit.

We know ISO 13485 & country-specific regulations inside and out.

Quality & safety are non-negotiables in the medical devices industry. Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service & delivery. We help organizations in the industry demonstrate their quality management processes and ensure best practice in everything they do.