Device Advice by RQM+

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Episodes

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RQM+ industry-leading experts and often special guests discuss regulatory, quality, clinical, lab, and reimbursement challenges MedTech companies are facing. RQM+ is the world's leading MedTech service provider offering consulting, clinical trial, lab, and reimbursement services, as well as technology solutions to support the entire product lifecycle. With more former FDA, Medicines, and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. Please visit RQMplus.com to learn more.

Episodes

Live! #5 — Chatting with Former FDA and Notified Body Representatives

This is the audio-only version of DEVICE LOVE Live! #5 , originally recorded May 14th, 2020. Join us for an open discussion with former FDA and Notified body representatives. What's it like moving from government to industry? What do they miss about their previous roles? Why do they prefer being in industryor do they? What do they wish both sides knew about the other? What are key takeaways to successfully navigate the system? Panelists: Ibim Tariah, Ph.D. Vice President of EU MDR and IVDR Consu...

May 15, 2020•40 min•Transcript available on Metacast

Live! #4 — Best Practices for Easing the Burden of a Medical Device Remediation Program

This is the audio-only version of DEVICE LOVE Live! #4 , originally recorded May 8th, 2020. Remediation programs at medical device companies are very hard on everyone involved.  DHF and manufacturing remediations resulting from government actions (FDA warning letters, EU's non-compliance reports) are the extreme.  The proactive efforts needed for many companies to achieve MDD compliance let alone the jump to MDR are no piece of cake either.   Remediation often exhausts the te...

May 12, 2020•38 min•Transcript available on Metacast

Live! #3 — Recent MDD and MDR Audit Findings: What are we seeing?

This is the audio-only version of DEVICE LOVE Live! #3 , originally recorded May 1st, 2020. Notified Body auditors have increased scrutiny as promised in both initial Medical Device Regulation (MDR) certification audits and routine Medical Device Directive (MDD) audits. Novel major findings are being issued on long standing processes and legacy products. In this panel discussion, R&Q experts will talk about what we are seeing across the medical device industry. Our experts will provide recom...

May 12, 2020•40 min•Transcript available on Metacast

Live! #2 — Use of FDA Emergency Use Authorization (EUA) process and EU MDR Article 59 to release devices needed for COVID-19 Public Health Emergency

This is the audio-only version of DEVICE LOVE Live! #2 , originally recorded April 24th, 2020. In response to the COVID-19 global pandemic, health authorities are taking the necessary steps to allow for greater access to and use of critical medical devices and PPE that are in short supply. However,some manufactures lack the necessary regulatory approvals needed to make their medical devices/PPE available. In situations such as these, both the United States (FDA) and European Union (European Comm...

May 12, 2020•30 min•Transcript available on Metacast

Live! #1 — Moving medical device manufacturing out of China

This is the audio-only version of DEVICE LOVE Live! #1 , originally recorded April 17th, 2020. The medical device industrys reliance on China for suppliers, manufacturing sites, and finished medical devices is widespread and well understood. In 2019, the U.S. President leveraged the International Emergency Economic Powers Act (IEEPA) in an effort to urge United States companies to begin searching for production alternatives outside of China. The act authorizes the President to regulate foreign e...

May 12, 2020•36 min•Transcript available on Metacast