Medical Device Posts

Next on the MedTech QMS Calendar

Next on the MedTech QMS Calendar

Phil Johnson, Senior Principal, IQVIA Quality Compliance

Medical Device and In Vitro Diagnostics (IVD) manufacturers have been busy the last few years ensuring that their Quality Management System (QMS) met the requirements of ISO 13485:2016 and the Medical Device Single Audit Program (MDSAP). It was an interesting time as Notified Bodies (NB) and certification bodies also came up to speed on the new requirements and increased level of surveillance on manufacturers. MDSAP introduced new auditing concepts and non-conformance handling, and also introduced a new level of compliance to Quality systems, resulting in a more rounded system for addressing global regulatory needs. (more…)

Considerations to Ready your Organization for the Approaching EU MDR Deadline

Considerations to Ready your Organization for the Approaching EU MDR Deadline

IQVIA Quality Compliance

EU MDR readiness isn’t just a single activity – and is not isolated to a company’s activities in the EU. It requires changes to processes across your organization.

As you prep for the looming EU MDR 2020 compliance deadlines, are you ready? These previously published blogs provide insight into the components of the medical device product lifecycle, from concept to market, that you need to consider in assessing your organization’s preparedness for the May 2020 deadline. (more…)

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…)

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…)

Florida Medical Manufacturers Consortium: 2018 Symposium Update

Florida Medical Manufacturers Consortium: 2018 Symposium Update

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

Established in 2003, the Florida Medical Manufacturers Consortium (FMMC) strives to unite, promote, and grow Florida’s Medical Device Industry and enhance the business success of its member companies. To that end, every year the Consortium hosts a Symposium to allow for industry networking, the expansion and sharing of industry knowledge and expertise, and to update its members on advocacy activities.

FMMC’s current advocacy activities occurring at the state and national level include:

  • Supporting Florida legislation fully exempting the purchase of manufacturing equipment (MME) from sales tax
  • Backing proposed legislation to reduce Florida’s sales tax on commercial rent
  • Working with national, regional, and industry advocacy groups in the fight to repeal the medical device excise tax

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Strategic Planning for the In Vitro Diagnostic Regulation (IVDR). Have You Spoken to Your CEO Yet?

Strategic Planning for the In Vitro Diagnostic Regulation (IVDR). Have You Spoken to Your CEO Yet?

Caroline Freeman, Principal Consultant, Consulting Services, IQVIA
Phil Johnson, Senior Director, Quality & Compliance Services, IQVIA

Despite having a longer transition of five years compared to the three years for the EU Medical Devices Regulation (EU MDR), the In Vitro Diagnostics Regulation (IVDR) provides IVD manufacturers with a much higher hurdle to jump over than the EU MDR1 for “general” IVD manufacturers. Due to this higher hurdle, IVD manufacturers must not sit back and wait for the commotion of the MDR to die down before implementing their transition.

Adding to the pressure of the May 2022 IVDR transition deadline, other, even shorter deadlines should force IVD manufacturers into action sooner. These include Health Canada’s mandate for adherence to the Medical Devices Single Audit Program (MDSAP), and the end of transition of EN ISO 13485:2016. (more…)

Strategic Planning for the EU Medical Devices Regulation: Have You Spoken to Your Notified Body Yet?

Strategic Planning for the EU Medical Devices Regulation: Have You Spoken to Your Notified Body Yet?

Caroline Freeman, Principal Consultant, Consulting Services, IQVIA
Phil Johnson, Senior Director, Quality & Compliance Services, IQVIA

We are now almost one-third of the way into the 3-year transition period for the EU Medical Devices Regulation (2017/745/EU) (MDR).

The MDR has significant economic impact on manufacturers — not just the cost of implementing the new regulations for new products, but ensuring legacy products meet the new requirements, as there is no grandfathering from the current EU Medical Devices Directive (MDD). The MDR has a big impact on distributors and importers, as well as manufacturers. This means that some distributors/importers (Economic Operators) of CE-marked products may cease their involvement under the MDR. The medical device supply chain is quite complex, often with involvement of multiple distributors, from manufacturers to patients. It is a global issue, as it affects all manufacturers/distributors that sell in to the EU.
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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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