Medical Device Posts

eMDR and UDI AS2 Gateway Messaging: Be Aware of Unintended Consequences

eMDR and UDI AS2 Gateway Messaging: Be Aware of Unintended Consequences

Bernard Jee, Product Manager, Pilgrim Quality Solutions

Keeping on top of regulatory updates is an ongoing challenge. Regulatory bodies are constantly making updates and Life Sciences organizations are expected to interpret these guidelines and fold them into their existing quality and compliance systems. We’re all aware that the cost of misinterpreting or ignoring these updates is high. That’s why it’s important not only to monitor these updates, but also to closely examine them for unintended consequences to the rest of your quality and regulatory processes. In this post, we’ll examine a recent update to FDA electronic submissions and shine a light on some unintended consequences and potential missed communication from this update.
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ISO 13485:2016 Compliance: Resources to Help You Get Started

ISO 13485:2016 Compliance: Resources to Help You Get Started

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

Transitioning to ISO 13485:2016 compliance is the top priority throughout the medical device industry right now. The industry is racing to absorb information on the latest version of the standard. Do you have a plan in place for getting your organization up-and-running with ISO 13485:2016? These resources will help you develop, fine tune, and implement your transition plan.
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The Case for Quality System Transformation

The Case for Quality System Transformation

Kari Miller, VP of Regulatory and Product Management, Pilgrim Quality Solutions

Recently, Pilgrim was a sponsor and a presenter at the American Medical Device Summit. The conference examined the challenges and opportunities currently facing the medical device industry. It also focused on the journey to best practices in the area of design, quality, compliance, technology, and strategy.

The quality track examined the value of creating an environment conducive to building a quality culture, with change management, harmonization, and collaboration as central themes. In fact, collaboration was a key theme throughout the conference as an element of innovation, risk management, sustainability, and compliance.
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MDSAP is Flying on Auto Pilot through 2016

MDSAP is Flying on Auto Pilot through 2016

Sandy Carson, Marketing Communications & Events Manager, Pilgrim Quality Solutions

In 2012, the International Medical Device Regulators Forum (IMDRF) identified a work group to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP). Forum members agreed that this global approach to auditing and monitoring medical device manufacturing could improve product safety and oversight on an international scale.
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ISO 13485:2016: Are you prepared for the transition?

ISO 13485:2016: Are you prepared for the transition?

Deb Kacera, Regulatory & Industry Strategist, Pilgrim Quality Solutions

How much effort will it take to get your organization ready for ISO 13485:2016? The new quality system requirement takes effect in March 2019. Medical device manufacturers that aren’t prepared for this change will need to do some heavy lifting to stay compliant with the updated standards.

Do you know if you need to do light or heavy lifting to get ready for the new version of ISO 13485? Here is some insight on where to start when reviewing changes between the old and new standard.
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Medical Device Complaint Handling: If you can’t stop the complaining, start the efficiency gaining.

Medical Device Complaint Handling: If you can’t stop the complaining, start the efficiency gaining.

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

Complaints can come from anywhere; it’s what you do with them that matters.

And when it comes to reportable events, time is what matters most. The clock begins ticking the moment your organization becomes aware of a complaint. Having an easy-to-use, intuitive medical device complaint handling system can make all the difference when you need to quickly get information to the FDA CDRH or any other regulatory body. Your organization may never be able to fully eliminate complaints, but it can improve their handling.

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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…)

UDI Resolutions: Ringing in the New Year with Compliance

UDI Resolutions: Ringing in the New Year with Compliance

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

Every year when January rolls around, there’s a cultural shift toward new beginnings and starting the year off right. Countless articles are published about making New Year’s resolutions, and gyms are packed with athletic hopefuls. People resolve to make self-improvements, even in their daily work lives.

A new year can signify the beginning of new projects or initiatives in the workplace, too. This typically includes setting goals to be more effective, efficient and productive than the prior year. (more…)

Medical Device Single-Audit Pilot: Will it Fly?

Medical Device Single-Audit Pilot: Will it Fly?

Sandy Carson Hessen, Marketing Communications Manager, Pilgrim Quality Solutions

We’ve all seen them. Some flop, some fly. Television Pilots — stand-alone episodes of television series used to sell shows to the networks by gauging whether a series will be successful. After seeing this sample of the proposed program, networks then determine whether the expense of additional episodes is justified.

There’s another type of pilot airing right now in the Medical Device industry, and the purpose is similar. (more…)