July 2014 Posts

electronic Medical Device Reports: 3 Reasons Med Device Manufacturers Should Go Electronic Now

electronic Medical Device Reports: 3 Reasons Med Device Manufacturers Should Go Electronic Now

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

We’ve already covered the impact of recent eMDR regulation updates on the industry (the overall benefits for patients and the health care community as a whole) in a previous post. Now let’s take a closer look at why medical device manufacturers may not want to delay their transition to electronic medical device reporting. (more…)

The ACK Facts: Truths About eMDR Acknowledgement Files

The ACK Facts: Truths About eMDR Acknowledgement Files

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

When it comes to adverse event reporting and eMDR, understanding how things work plays a role in your organization’s success. This is especially true with acknowledgement files (ACKs), as they determine whether you have met your regulatory reporting requirements. (more…)

The Role of the Internal Quality Auditor

The Role of the Internal Quality Auditor

Konyika Nealy, Vice President of QA and Validation, Pilgrim Quality Solutions

As an experienced member of your organization you may at some time be called upon to conduct an internal audit. This is a good thing. Internal audits are intended to preempt issues that can arise during a second or third party audit. This type of peer review though, if not managed correctly, can have negative consequences that undermine its value.
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FDA Final Ruling on electronic MedWatch reports: The Impact on the Industry

FDA Final Ruling on electronic MedWatch reports: The Impact on the Industry

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

Have you heard the big news? All mandatory 3500A MedWatch reports submitted by medical device manufacturers and importers must be now submitted electronically. On February 14, 2014, the FDA released its final decision on electronic Medical Device Reporting (eMDR). By August 14, 2015, all medical device manufacturers and importers will be required to submit mandatory 3500A MedWatch reports electronically to the FDA’s Center for Device and Radiological Health (CDRH). We’ve been waiting for this final decision since 2009 when the rule was proposed and opened for public comment. (more…)