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Henry Macartney

Recent Posts

Premarket Submissions of Medical Devices

March 11th, 2016 by Henry Macartney

In a recent quarterly 2015 report, the US Food and Drug Administration (FDA). [...] Read More

Posted in Premarket Submissions

Key Characteristics of FDA Part 11 Compliance

February 4th, 2016 by Henry Macartney

Properly managing sensitive information to maintain privacy and security has. [...] Read More

Posted in FDA & European Regulations

The EU Influence on Medical Devices & Their Manufacture

August 20th, 2015 by Henry Macartney

Excluding the United States, European recommendations for medical device. [...] Read More

Posted in Medical Device Manufacturing Compliance

Outsourcing and the Device Manufacturer’s QMS Accountability

August 6th, 2015 by Henry Macartney

In 2003, the International Organization for Standardization (ISO) issued ISO. [...] Read More

Posted in Medical Device Quality Management Systems

A Flexible Approach to 21 CFR 820 Compliance

June 11th, 2015 by Henry Macartney

The Quality Systems (QS) Regulations of FDA 21 CFR 820 are general standards. [...] Read More

Posted in Quality Systems Regulations

Deciphering the FDA Medical Device QSR

May 1st, 2015 by Henry Macartney

As a medical device manufacturer, how do you identify your compliance. [...] Read More

Posted in Quality System Regulation

Medical Device Compliance: Recovering from FDA Warning Letters

April 21st, 2015 by Henry Macartney

You've received one of the dreaded FDA Warning Letters. The last thing you want. [...] Read More

Posted in Medical Device Compliance

How Do Medical Device Manufacturers Maintain Data Integrity?

April 2nd, 2015 by Henry Macartney

Is cybersecurity something you consider when designing a new product? As. [...] Read More

Posted in FDA & European Regulations

Deciphering EU Cybersecurity Plans and Policies

March 25th, 2015 by Henry Macartney

By default, your desire to market products in Europe makes EU cybersecurity. [...] Read More

Posted in governance techniques

Choosing the Most Effective IT Infrastructure Qualification Strategies

January 27th, 2015 by Henry Macartney

Are you sure your IT infrastructures are fully qualified, or is it possible. [...] Read More

Posted in Software Validation

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