Finding the Balance – Part 2: Where EU MDR and EU GDPR Intersect

Finding the Balance – Part 2: Where EU MDR and EU GDPR Intersect

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

The EU Medical Device Regulation (MDR), which went into effect in May 2017, is a complex and demanding regulation. In May of 2018, we were all introduced to the data protection requirements of the EU General Data Protection Regulation (GDPR). In the first part of this 2-part blog series, Finding the Balance, we examined key areas of EU MDR that need to be viewed through an EU GDPR lens. This second installment takes on the considerations of how organizations can comply with both regulations.

Every organization’s products and situation will be different, so offering a canned To Do list would not be effective. Each organization needs to work with its legal counsel and security group to determine the right approach for their organization. In Part 1, we outlined the three major categories of GDPR. It’s within these categories that EU MDR and EU GDPR intersect. (more…)

The Balancing Act between EU MDR and EU GDPR – Part 1 in a Series

The Balancing Act between EU MDR and EU GDPR – Part 1 in a Series

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

Meeting the reporting and legal requirements of regulations, such as the EU Medical Device Regulation (MDR) and the recently mandated EU General Data Protection Regulation (GDPR), can be a daunting task. An initial review of both regulations brings forth seemingly clashing requirements. In fact, the balancing act that needs to occur within an organization to comply with both is a delicate one.

This is the first of two blogs that will look at the components of EU MDR and EU GDPR. I will address the potential impact of EU GDPR on EU MDR, with a particular focus on Complaints processing and Vigilance and Safety Reporting. In part two, I’ll outline the areas where these two EU-based regulations intersect. (more…)

Why Supplier Management Belongs in your Enterprise QMS

Why Supplier Management Belongs in your Enterprise QMS

Joshua Centner, Industry Solutions Group Manager, Pilgrim Quality Solutions, an IQVIA company

In over a dozen years as a sales engineer, and now as manager of that team, I have heard numerous recurring questions raised about specific topics when speaking to clients about their software needs and what processes belong in which systems.

One topic that has arisen over the past few years is best practices for supplier management. Should supplier management, and specifically supplier onboarding and maintenance, be a function of the Enterprise Resource Planning (ERP) system or the Quality System? This is by far the most common and most debated element. (more…)

Fusion 2018: Pilgrim Quality, IQVIA, and Next-Generation Quality

Fusion 2018: Pilgrim Quality, IQVIA, and Next-Generation Quality

Dan Jacob, Research Director, LNS Research

Pilgrim Quality Solutions last month hosted an enjoyable, inspiring, and valuable global customer conference, Fusion 2018, in Tampa, Florida. This year’s conference provided an opportunity for attendees to learn about Pilgrim’s strategy to drive the Next-Generation Quality vision, and to share the exciting benefits that Pilgrim, now as part of IQVIA Technologies, can provide to its customers. (more…)

The Benefits of Supplier Management

The Benefits of Supplier Management

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

Supply chain risks grow as an organization’s suppliers expand geographically and companies increase offshoring and outsourcing activities. The increasing sophistication in technology, and ever-increasing regulatory oversight, are additional factors in the increased supply chain risk. Resulting supply chain issues are impacting medical device and pharmaceutical manufacturers around the globe, costing billions of dollars in market devaluations, recalls, regulatory fines, and settlements. But supplier management is a viable tool in the arsenal to minimize the risk of those outcomes. (more…)

The Medical Device Regulatory Landscape is Impacting Supplier Control

The Medical Device Regulatory Landscape is Impacting Supplier Control

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

Ask any corporate executive to list the top objectives of their organization’s Quality department and they’ll include the need for predictive and proactive risk management strategies. The Medical Device industry is no exception to this reality; if the industry wants to improve patient outcomes, then it has to manage risk.

One of the largest sources of organizational risk is dependence on third-party suppliers. Today’s global economy has added complexity to supply chains, and longer supply chains are making it increasingly difficult to manage our suppliers, and in many cases our suppliers’ suppliers, thereby increasing overall risk. The plethora of medical device regulatory requirements placed in Medical Device organizations, including FDA mandates and the updates to ISO 13485:2016, reflect this new reality. (more…)

Planning for the medical device market: Getting the edge from post-market surveillance

Planning for the medical device market: Getting the edge from post-market surveillance

Pam Weagraff, Director MedTech Regulatory, IQVIA
Phil Johnson, Senior Principal, Quality and Compliance Services, IQVIA

Robust, predictive post-market surveillance systems that monitor medical device safety after launch, reduce both costs and demands on resources and increase product safety and performance. However, as competition intensifies, could it be time to revisit the approach?

The historical role of post-market surveillance (PMS) of medical devices has been reactive. It has focused on collating and reporting adverse events, such as device malfunctions or patient injuries, in order to trigger product returns, modifications, exchanges and recalls as necessary. However, as medical device complexity increases, PMS approaches will need to be more rigorous, leading to earlier detection of potential product failures in the field. (more…)

Supplier Management Validation: What’s Your Plan?

Supplier Management Validation: What’s Your Plan?

Ninoshka Ortiz, Senior Validation Specialist, Pilgrim Quality Solutions, an IQVIA company

To fulfill the needs of trending technologies and Life Science needs, a global supplier management program helps to integrate an appropriate level of assurance that suppliers and vendors are able to consistently supply quality of materials and services that are in compliance with regulatory requirements.

Have you considered whether your integrated supplier management program:

  • Is validated to effectively help your company to asses, manage and monitor supplier qualifications, and risk and compliance across your global supply chain process?
  • Is consistently producing the expected results for the intended use that your company is continuously seeking?

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Exploring Supplier Quality Management for MedTech

Exploring Supplier Quality Management for MedTech

Phil Johnson, Senior Principal, Quality and Compliance Services, IQVIA

As MedTech manufacturers, do you have the right business and regulatory processes in place to manage your respective supplier management responsibilities? Last week, I presented Part 2 of Pilgrim Quality Solutions’ 4-part webinar series, Quality In, Quality Out, taking an in-depth look at supplier quality management (SQM) processes for both medical device and in-vitro diagnostic medical device manufacturers. The key takeaway from the presentation? These manufacturers need to secure and maintain effective supplier agreements to manage both the regulatory and business needs of the product/material or service being provided.

During this on-demand webinar, I laid out the regulatory drivers for supplier management for medical device manufacturers and the importance of Quality in the evaluation, monitoring, and approval of suppliers. I also provided guidance for suppliers regarding how they manage their relationships with the legal manufacturers of the product. At the conclusion, I brought it all together by highlighting the prominence of SQM-related FDA 483s. (more…)

Supplier Quality Management in the Medical Device Industry

Supplier Quality Management in the Medical Device Industry

Daryl Oldham, Product Marketing Manager, Pilgrim Quality Solutions, an IQVIA company

When I recapped the first webinar in Pilgrim Quality Solutions’ Quality In, Quality Out: Supplier Quality Management four-part series, I started my blog with two questions:

  • Do you have the proper process in place to evaluate, monitor, track, and rate your suppliers?
  • How confident are you that you can rely on your suppliers or even that you are protected from issues your suppliers encounter at any of their locations?

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