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Henry Macartney

Dr. Macartney began his career within the medical device and pharmaceutical fields where he was involved in research and development before moving to the central computer division of the company’s research division located in Upper Bavaria, Germany. In 1996 he started his career in the consulting industry. An industry-wide recognized expert who has issued various publications supporting industry standards, Dr. Macartney is also referenced by the National Academy of Sciences.

Premarket Submissions of Medical Devices

March 11th, 2016 by

Medical DevicesIn a recent quarterly 2015 report, the US Food and Drug Administration (FDA) stated that major [...] Read More

Key Characteristics of FDA Part 11 Compliance

February 4th, 2016 by

Ultrasound Properly managing sensitive information to maintain privacy and security has become paramount in recent years. Today, [...] Read More

The EU Influence on Medical Devices & Their Manufacture

August 20th, 2015 by

Surgical Scissors Medical Device[...] Read More

Outsourcing and the Device Manufacturer’s QMS Accountability

August 6th, 2015 by

Global Medical Technology ComplianceIn 2003, the [...] Read More

A Flexible Approach to 21 CFR 820 Compliance

June 11th, 2015 by

Medical Device ComplianceThe Quality Systems (QS) Regulations of FDA 21 CFR 820 are general standards that [...] Read More

Deciphering the FDA Medical Device QSR

May 1st, 2015 by

Medical Device ManufacturingAs a medical device manufacturer, how do [...] Read More

Medical Device Compliance: Recovering from FDA Warning Letters

April 21st, 2015 by

FDA Warning LetterYou’ve received one of the dreaded FDA Warning Letters. The last thing you want is to delay the launch of your company’s [...] Read More

How Do Medical Device Manufacturers Maintain Data Integrity?

April 2nd, 2015 by

Data Integrity[...] Read More

Deciphering EU Cybersecurity Plans and Policies

March 25th, 2015 by

Cyber SecurityBy default, your desire [...] Read More

Choosing the Most Effective IT Infrastructure Qualification Strategies

January 27th, 2015 by

IT Infrastructure Qualification Strategies[...] Read More