2018 Posts

Happy Holidays from the Pilgrim Quality Blog Team

Happy Holidays from the Pilgrim Quality Blog Team

It has been our pleasure this year to share with you our perspectives on the latest topics in quality, compliance, and risk management. We wish you a wonderful holiday season and a prosperous 2019.
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MedTech Company of the Year 2018 Finalists

MedTech Company of the Year 2018 Finalists

MDDI Staff, MD+DI Magazine

Medical Device and Diagnostics Industry (MD+DI) Magazine announced it’s 2018 list of finalists for MedTech Company of the Year. The industry publication named Boston Scientific among the list of 10 companies that have “risen above the rest in 2018.” For over a decade, both IQVIA and Pilgrim Quality Solutions, an IQVIA company, have enjoyed a long-standing relationship with industry leading Boston Scientific. MD+DI cited Boston Scientific’s aggressive Mergers & Acquisition strategy. In July, the company’s CEO Mike Mahoney “reassured investors that the firm’s M&A appetite was part of a very well laid out plan.” (more…)

Proactive Post-Market Surveillance: Medical Devices and IVDs

Proactive Post-Market Surveillance: Medical Devices and IVDs

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

Designing the organization and process for the future

Post-market surveillance in Medical Devices & IVDs (MedTech) has traditionally been reactive. It has focused on investigation and reporting adverse events, device malfunctions, or patient injuries in order to trigger product returns, modifications, exchanges, and recalls as necessary. However, as medical device complexity increases, Post-market surveillance will need to be more rigorous, leading to earlier detection of potential product failures in the field.

Regulatory authorities are starting to emphasize the importance of Post-market surveillance plans that are based on proactive data gathering and analysis, rather than relying on reactive data gathering once a post-market event has been reported. To meet these needs, manufacturers should take a risk-based approach when considering clinical and post-market planning. (more…)

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 needs medical device regulation risk management.

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…)