Optimizing CAPAs in the Medical Device Industry

by | Dec 11, 2020 | Medical Devices

The corrective actions and preventive actions process, simply referred to as the CAPA process, is one of the backbones of any QMS. Whether you are in the automotive, medical device, aerospace, or any other industry, if you have a QMS, you will need a CAPA process. Additionally, any firm that has an ISO certified QMS, be it ISO 9001, IATF 16949, ISO 22000, or ISO 13485, is required to implement and maintain a CAPA process. The medical device industry, however, has a special tie to CAPAs as every firm is legally obligated to implement the process per 21 CFR § 820.100. How a medical device firm utilizes the CAPA process can be the difference between a highly successful operation or an operation that has systemic issues and is bogged down with inefficiencies.

In this whitepaper, we will explore how to best utilize CAPAs in the medical device industry including best practices, common pitfalls, and how to avoid “death by CAPA”. This paper will also discuss the purpose and basic principles of CAPAs, as well as how the process has developed over time.

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Madison Wheeler

Madison Wheeler

Director of Technical Operations - Ms. Wheeler serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Ms. Wheeler also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Ms. Wheeler holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA), and is currently pursuing her M.S. in Quality Management.

More Resources

FDA Adverse Event Reporting 

FDA Adverse Event Reporting 

When reporting an Adverse Event to the Food and Drug Administration (FDA) the best method is to utilize the FDA Adverse Event Reporting System (FAERS). FAERS is a database that contains adverse event reports, product quality complaints that led to an adverse event, and medication error reports1. All FAERS reports are easily accessible to the public. 
De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.

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