CAPA and P&PC:
How to Handle These Two Medical Device Compliance Troublemakers

FDA QMS subsystems CAPA and P&PC

What can FDA’s data tell you? Sometimes you learn something new ‒ other times the data validates what you already know. FDA’s CY 2016 Annual FDA Medical Device Quality System Data reveals that Corrective and Preventive Action (CAPA) and Production and Process Controls (P&PC) continue to cause compliance headaches for medical device manufacturers. The data addresses findings related to five quality system subsystem areas: Corrective […]

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FDA Proposes Expanding the List of 510(k)-Exempt Devices:
What You Need to Know

FDA 510(k) exempt update

What: On March 14, 2017, FDA published a formal notice proposing to make hundreds of Class II medical devices exempt from premarket notification requirements that necessitate a 510(k) submission.* Note that there are a few exceptions for specific indications of medical devices. All devices will still need to meet other FDA requirements, such as 21 CFR 820 Quality System Requirements. We view this shift as […]

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Assembling a Comprehensive Risk Management Approach:
A Case Study

Our customer, like many medical device manufacturers, had numerous risk management activities occurring in isolation. Risk management was addressed in design, manufacturing, validation, CAPA, complaints, and other areas, but there was no comprehensive process that served the business or could be articulated to an auditor. In addition, the company’s risk management files were static – the company was not updating the files with post-production, post-market, […]

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The Medical Device Single Audit Program (MDSAP):
What You Need to Know

What Is MDSAP? The Medical Device Single Audit Program – or MDSAP – allows a single regulatory audit of a medical device manufacturer’s quality management system to satisfy the requirements of multiple regulatory authorities (RAs). Five RAs: Australian Therapeutic Goods Administration (TGA), Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, MHLW/PMDA (Japan), and the US Food and Drug Administration (FDA) participated in a three year MDSAP […]

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The New EU In Vitro Diagnostic (IVD) Regulation:
What You Need to Know

EU's In Vitro Diagnostic Regulation Update (IVDR)

In May 2016, European Union (EU) institutions agreed to draft text for the In Vitro Diagnostic Device Regulation (IVDR) that will replace the existing In Vitro Diagnostic Devices Directive (IVDD) 98/79/EC. The new regulation introduces significant changes for IVD manufacturers that currently hold a CE Mark or plan to market their products in Europe. To start getting ready, Oriel STAT A MATRIX has compiled a list […]

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