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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 deficiency letters were issued to 67% of premarket approval applications. Such deficiencies in applications can hold up premarket approvals – sometimes more than 180 days.

It is [...] 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, pharmaceutical companies and medical device manufacturers are increasingly using the Internet to broaden their services making compliance with FDA regulation even more important.

As a [...] Read More

The EU Influence on Medical Devices & Their Manufacture

August 20th, 2015 by

Surgical Scissors Medical DeviceExcluding the United States, European recommendations for medical device manufacturers are important and globally influential factors. Businesses seeking to distribute products in [...] Read More

Outsourcing and the Device Manufacturer’s QMS Accountability

August 6th, 2015 by

Global Medical Technology ComplianceIn 2003, the International Organization for Standardization (ISO) issued ISO 13485, officially known as EN ISO 13485:2003. This voluntary international standard provides a framework to assist medical [...] 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 apply to finished devices, that are intended for human use.. Rather than impose strict requirements, the regulations offer manufacturers of these devices an opportunity to [...] Read More

Deciphering the FDA Medical Device QSR

May 1st, 2015 by

Medical Device ManufacturingAs a medical device manufacturer, how do you identify your compliance obligations? Companies that want to fulfill their duties properly generally look to FDA 21 CFR 820, the Quality System Regulation and the 21 CFR 800 series of [...] 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 IntegrityIs cybersecurity something you consider when designing a new product? As medical devices become more and more interconnected, the data they generate, store and share becomes more [...] Read More

Deciphering EU Cybersecurity Plans and Policies

March 25th, 2015 by

Cyber SecurityBy default, your desire to market products in Europe makes EU cybersecurity compliance one of your primary organizational goals. Unfortunately, the path to effective regulatory adherence [...] Read More

Choosing the Most Effective IT Infrastructure Qualification Strategies

January 27th, 2015 by

IT Infrastructure Qualification Strategies[...] Read More