Electronic Regulatory Reporting Posts

Strategies for Electronic Medical Device Reporting (eMDR) Success [free e-book]

Strategies for Electronic Medical Device Reporting (eMDR) Success [free e-book]

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

We’ve all been anticipating the final electronic reporting deadline since last Valentine’s Day when the deadline of August 14, 2015 was first announced. Are you ready? For all medical device manufacturers and importers out there, don’t get stuck with a less than ideal process just to meet this deadline. Get your complimentary e-book to arm your company with knowledge you need to build a successful electronic medical device reporting process that works best for you.

Whether or not you are already submitting your medical device reports electronically, this e-book can help you understand how the process works, and design a great eMDR process to meet your mandatory reporting requirements. Learn tips from companies who were the first to implement, and get a handle on all the steps you will need to follow. (more…)

Electronic MedWatch Reporting: eMDR Testing with CDRH (Free E-Book)

Electronic MedWatch Reporting: eMDR Testing with CDRH (Free E-Book)

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

A few months back, we hosted a webinar on the eMDR Countdown to Compliance during which we learned that from beginning to end, the transition to electronic medical device report submissions (electronic MedWatch or FDA Form 3500A reporting) can take between four to six months. But how do you really know that you’re ready to comply with the new mandate?

Today, let’s point the microscope at one piece of the puzzle: testing your electronic medical device report submissions with the FDA’s CDRH. Testing gives you the opportunity to identify and correct trouble areas before you transition to production electronic reporting. (more…)

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…)

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…)

Five Key Essentials for a Good Electronic Document Management System

Organizations need to accommodate continuous improvement activities, daily operations and change that correspond to document content – administering all these documents, making it accessible and keeping it current. Today’s regulated companies must track and manage all documents from different departments, plant locations, customers, vendors and regulatory agencies. To be competitive, a firm must automate its handling of documents with an effective electronic document management system (EDMS). EDMS is a set of products and services that lets users electronically store, locate, retrieve, share and track documents. (more…)

FDA tells Drug Makers, “Just the Facts, Ma’am”

Beginning in March 2011, companies testing experimental drugs or medical products will be required to inform the FDA within 15 days about serious risks and adverse reactions that arise during clinical studies (FDA, Sept. 2010). This isn’t anything new … the FDA just wants to make it simpler. The final rule is a revision of a proposed rule that was issued in March 2003. Apparently, many companies were piling information on the FDA in droves, making it harder for the agency to sift through the data quagmire to find the necessary information. Wanna make it easier on yourself and the FDA? Think Electronic Regulatory Reporting.
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