Arena Blog

Pass Your Medical Device Audit with Confidence

linked-in icon twitter-icon facebook-icon

confidenceWhen the auditor comes knocking on your door, will you be ready?

For medical device manufacturers, surviving an audit can be nerve-racking. In the back of your mind, you know the stories of how companies on the FDA watch-list frighten away potential customers and investors. And you’re not alone. The audit process can be scary for established medical device companies too.

On Tuesday, April 4, join Apical Instruments’ Director of Regulatory Affairs/Quality Assurance Kim Khoe and Arena Solutions’ Director of Compliance Yelena Bolton for a webinar that will walk you through a step-by-step real world example of how to pass an audit exam with flying colors.

In this 45 minute webinar, you’ll learn:

• How to show the auditor you do what you say 

• How Arena helps medical device companies with FDA compliance and audits

• How product-centric QMS solutions enable medical device companies to achieve and maintain regulatory compliance and reduce project/compliance cost

Sign up today and learn tangible real-world advice to achieve compliance. Your days of hiding under your lab desk to evade an auditor’s request for evidence are over! You can face the auditor with confidence and swagger.

We are a huge fan of Apical's brilliant Kim Khoe whom we are thrilled to be having speak at this webinar. She’ll share how Arena helped streamline Apical Instruments ECO processes, eliminated expensive IT teams and improved compliance approval success. You’ll also discover how Apical’s ECOs went from months to days and how they saved $10,000 from eliminating manual sharing of files and $100,000 by removing IT costs. 

“I always insisted upon Arena,” says Khoe. “Arena can do it all: manage your bill of materials (BOM), quality system, documents, device returns, nonconformance and your entire CAPA.” 

So, what are you waiting for? Register today to hear more from Kim Khoe on April 4th. (And don’t worry, if you can’t attend the live event, register to get the on-demand copy). 

About the Author

John Papageorge

John Papageorge has worked at some of the biggest names in the high tech industry, launching products and programs for companies, such as Oracle, HP, Cisco, and Microsoft. John's passion ...

Read More 


Arena Furthers Commitment to Offering Robust Single Product Development Solution In part III of our interview with 1factory’s super smart President Nipun Girotra outlines challenge, in painful detail, impacting today’s ...
Read more

How Integrating PLM with a Component Database Reduces Open Heart Surgery Bloopers How an all-in-one product development platform can help reduce an increasingly broader array of risks and pains that afflict and ...
Read more

Here’s a PLM Pop Quiz, Hotshot If you keep using spreadsheets to manage your PLM processes then version control errors are going to occur, leading to ...
Read more