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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

10 CAPA Tips for the Medical Device Industry

January 27th, 2016 by

Male Scientist Using Medical ToolsThe CAPA process from the side of regulatory compliance of both U.S. FDA requirements (21 CFR 820.100) and EU regulatory requirements ([...] Read More

How to Avoid Pharmaceutical Data Integrity Issues

January 22nd, 2016 by

Pharmacists in LabIn 2015, the US Food and Drug Administration (USFDA) issued Warning Letters to eight pharmaceutical companies for the lack of data integrity. According to the USFDA, data integrity means, “presence of accurate and reliable data in an application submitted to the [...] Read More

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

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

Anticipating FDA Initiatives for Risk Management

May 6th, 2015 by

Guidelines Rules and ComplianceRegulatory bodies like the FDA enact initiatives on a routine basis. While their timing [...] Read More