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Advice from medical device startups on preparing for an FDA or ISO audit

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In our many years of working with medical device manufacturers, we’ve seen the rigorous work these companies do to pass a regulatory audit. Preparing for an audit is a time-consuming process that involves gathering, reviewing and updating process documents and ensuring that employees are fully trained on all company procedures. Needless to say, with their company’s success hinging on the outcome of the review, most find their FDA or ISO audit to be a nerve-wracking and stressful experience.

We interviewed three medical device companies–all of whom successfully managed their first audits–to get their take on how to prepare. All are Class II medical device manufacturers, and at the time of their audits none were offering predicates of their own devices, making it vital that they passed their inspections. All agree that if there’s an FDA or ISO audit in your future, you will benefit from taking the time to organize your procedures, documents and data in a clear and logical order. Their advice is described in detail in an article on the Arena website, but it can be summarized in the five tips below.

Preparing for an audit: Five tips for medical device manufacturers

  1. Document your standard operating procedures (SOPs): Capture sufficient detail in your procedures to thoroughly document your activities.

  2. Train your people: Spend the time and effort needed to make sure your team understands and complies with regulatory standards.

  3. Control, track and manage your data electronically: Digital records of your processes, design history file (DHF), device master record (DMR) and bills of materials (BOMs) show your commitment to quality, accuracy and thoroughness.

  4. Audit yourself: Empower your internal auditors to make changes or hire a third-party service to perform a mock audit.

  5. Have the proof at your fingertips: The faster you can provide evidence to your auditor, the better his or her impression of your business will be.

Following the steps above can help boost your confidence going into an audit and help pave the way for a positive outcome. Read the full article to learn more about how the three medical device startups successfully addressed the challenges they encountered during their own audits. And if you have any of your own tips on how to prepare for an audit, we’d love to hear them.

About the Author

Michelle LaVery

Michelle’s focus at Arena is online marketing, including managing pay-per-click programs and helping more manufacturers find Arena on the worldwide web. She has worked at Arena since 2001 and loves ...

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