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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

10 CAPA Tips for the Medical Device Industry

January 27th, 2016 by Zuhdi Hussein

The CAPA process from the side of regulatory compliance of both U.S. FDA. [...] Read More

Posted in Medical Device Quality Management Systems

How to Avoid Pharmaceutical Data Integrity Issues

January 22nd, 2016 by James Francum

In 2015, the US Food and Drug Administration (USFDA) issued Warning Letters to. [...] Read More

Posted in Pharmaceutical Data Integrity

What Data Integrity Means to Device Manufacturers

August 28th, 2015 by Zuhdi Hussein

Data integrity is an ever-increasing concern in life sciences, with medical. [...] Read More

Posted in Quality Management Systems

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

Complying with eMDR FDA Regulations

August 14th, 2015 by James Francum

In February of 2014 the Food and Drug Administration (FDA) published the final. [...] Read More

Posted in HL7ACSR

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

Anticipating FDA Initiatives for Risk Management

May 6th, 2015 by James Francum

Regulatory bodies like the FDA enact initiatives on a routine basis. While. [...] Read More

Posted in Risk Management

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