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Ask the Expert: EU MDR

In interview, medical device, medtech, Q&A, regulations by Alicia CheungLeave a Comment

HCL hosted a Lunch & Learn Roundtable Discussion at the American Medical Device Summit 2018 last month in Chicago, IL. The session, “Ask the Expert – MDR and Lifecycle Management”, was led by Associate Vice President, Hilde Viroux. Hilde addressed questions surrounding the uncertainty of EUDAMED and UDI, the transition period, and how to obtain compliance. This is an excerpt from an interview Generis Group did with Hilde Viroux, AVP, Regulatory of HCL, America Inc. prior to the American Medical Device Summit 2018. “What are some of the biggest challenges in the new MDR that will impact device manufacturers? There are a lot of changes in the EU MDR that impact device manufacturers. Generating clinical data for all devices, developing the required reports and updating technical files to be compliant with Annex II and III is where most of the budget will typically go. In addition, there is the requirement to trace hazardous substances in devices and identify them on the label. The new regulation also requires manufacturers to set up a proactive approach to following the performance and safety of the device throughout its lifecycle.”

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Reduce Supplier Risk, Reduce Organizational Risk

In compliance, medical device, medtech, quality, regulations by Alicia Cheung1 Comment

Risk is a major focus in most businesses today, regardless of industry. In the past few years, the Life Sciences have seen a steady rise in supply chain issues resulting in lost market caps, recalls, regulatory fines, and other financial impacts valued in the billions of dollars. The Medical Device Industry is no exception to this reality; if the industry wants to improve patient outcomes, then it has to manage risk. According to Pilgrim Quality Solutions, 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 suppliers, and in many cases, suppliers’ suppliers, thereby increasing overall risk. The plethora of regulatory requirements placed on Medical Device organizations, including the updates to ISO 13485:2016, reflect this new reality.

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Global Regulatory Intelligence: Evaluating the Developments to the EU MDR

In compliance, medical device, regulations by Cressida MurrayLeave a Comment

Is your company prepared for the new EU MDR? Michael Santalucia, Vice President of Global Regulatory Affairs for Terumo BCT, is responsible for managing the global regulatory affairs function regarding the development and execution of product submission strategies for the company’s medical devices, regulatory compliance requirements, and industry advocacy. As medical device companies face large regulatory challenges to comply with the new European Union Medical Device Regulation (EU MDR), we sat down with Michael Santalucia to learn how Regulatory Affairs organizations are evolving along with global regulations, what Terumo BCT has been doing to comply with EU MDR, and how members of the medical device industry can stay informed. “The EU MDR is arguably the most important legislation to affect our industry in the last two decades. Because of the impact this will have for any firm with CE marked devices, it is essential to have someone in the organization that can provide the company with advice and guidance to the requirements that have been established and those that are yet to evolve.”

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