May 2015 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…)

ISO 9001:2015 and the 8 Quality Management Principles to Take You to the Head of the Class

ISO 9001:2015 and the 8 Quality Management Principles to Take You to the Head of the Class

Sandy Carson Hessen, Marketing Communication Manager, Pilgrim Quality Solutions

For more than half a century, the International Standard for Organizations (ISO) has been developing standards to protect society from potential errors. It’s been 26 years since the introduction of the Quality Management System standards model, ISO 9001, specifically.

The most current version, ISO 9001:2008 was adopted to address fulfilling regulatory requirements and customer satisfaction through continuous improvement of the quality system. The standards apply worldwide and provide consumers with a base-level confidence in an organization’s ability to provide conforming products. Theoretically, it’s been working, but for those concerned with quality, it certainly makes sense to evaluate whether there’s room for improvement. (more…)