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What Data Integrity Means to Device Manufacturers

August 28th, 2015 by

Data SecurityData integrity is an ever-increasing concern in life sciences, with medical device manufacturers feeling much of the conformity backlash. There continues to be heightened regulatory focus on diverse cybersecurity topics, including data integrity.

Public and private sector organizations [...] 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

Complying with eMDR FDA Regulations

August 14th, 2015 by

Medical Lab TechnicianIn February of 2014 the Food and Drug Administration (FDA) published the final rule that all major importers as well as foreign and domestic manufacturers of medical devices must submit their medical [...] 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