Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees.

🔦 Today, we're back with a BONUS Excellence Spotlight video featuring two case studies from Vice President of Technical, Jonathan Gimbel. Here's a link to Jon's original feature if you haven't seen it.

While these case studies will obviously demonstrate Jon's wealth of experience in action (even though he's shy about it!), we also hope they demonstrate the true depth of expertise at RQM+ and our dedication to helping clients through a multitude of challenges, including navigating the complex landscape of regulations and quality standards.

👷‍♂️ Case Study 1: From Ground Up to Success 👷‍♂️
Jon collaborated with a small company that had a groundbreaking wound healing device for negative pressure wound therapy. With a strong belief in their product but limited regulatory understanding, Jon and the RQM+ team stepped in. They meticulously audited the company, identified gaps, and much more. From developing a comprehensive quality system to guiding them through FDA audits and even drafting the 510(k) submission, this partnership yielded a full-service solution.

🏥 Case Study 2: Transforming Adversity into Collaboration 🏥
Amid recalls and warning letters, RQM+ played a pivotal role in restoring harmony at a company facing challenges with understanding FDA requirements. By assisting in recall resolutions, obtaining critical 510(k) submissions, and fostering a collaborative relationship with the FDA, Jon and the team transformed an adversarial dynamic into a collaborative one.

Again, we hope these case studies demonstrate RQM+'s commitment to supporting clients through every twist and turn! At RQM+, we're thankful for Jon's deep knowledge and leadership.

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🎬 In our latest MedTech Voices clip, RQM+ VP of Intelligence and Innovation Jaishankar Kutty, Ph.D. and Medical Director Sally Sennitt delve into the EU MDR expert panel feedback about a groundbreaking minimally invasive tricuspid valve.

Why watch? 🤔

1️⃣ Gain a comprehensive understanding of the intricate balance between benefit and risk as the clip explores the imperative of a Randomized Controlled Trial (RCT) for precise evaluation against guideline-driven medical therapy. The significance of an extended follow-up period is also underscored.

2️⃣ Navigate Post-Market Clinical Follow-up (PMCF) planning, as Sally and Jai dissect the study design's nuances, delineate the pursuit of well-defined endpoints, and scrutinize the determination of acceptable reduction in TR.

3️⃣ Uncover the convergence of regulatory and clinical considerations that ultimately led the expert panel to their decisive determination regarding the device's market readiness.

We'd love to hear any thoughts or questions you have about this episode in the LinkedIn comments! Thank you for listening. 🙏

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📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use ⁠⁠⁠⁠⁠our contact form⁠⁠⁠⁠⁠.

When we say we have thought leaders at RQM+, we mean it. 👑

Small in duration but big in substance, this four-minute MedTech Voices clip features Senior VP of Intelligence and Innovation Amie Smirthwaite, PhD, FRAPS sharing her ISO 18969 journey.
 
We don't want to say too much because we'll spoil the clip!
 
What we will say is that Amie's initiative is leading to the development of the first ISO standard for clinical evaluation of medical devices. Work is ongoing; while the standard will be harmonized, it's intended to be applicable to any regulatory geography, and emphasizes a scientific approach rather than addressing specific regulations.

Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees.

🌟 Today as part of our Excellence Spotlight video series we're celebrating RQM+ Principal Regulatory Scientist, Bethany Knorr Chung, PhD, RAC!

🔢 Bethany is a driving force behind our clinical and post-market operations group. With an exceptional background in math, biology, and biomedical engineering, she's truly a maestro of all things quantitative.

👪 Bethany's journey is a testament to her unwavering commitment to excellence personally and professionally. Following a brief hiatus to prioritize her family, she made a powerful comeback to the workforce. Her technical expertise and passion for what she does allows her to fearlessly dive into diverse projects, from catheters to neural implants.

🥇 As she covers in this clip with Jaishankar Kutty, Ph.D., Bethany's proudest achievement lies in revolutionizing quantitative benefit-risk analysis. Her pioneering method, lauded by reviewers, adds a new dimension to our industry's understanding.

Thank you, Bethany, for all you do for RQM+ and our clients!

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📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use ⁠⁠⁠⁠⁠⁠⁠our contact form⁠⁠⁠⁠⁠⁠⁠.

This show was recorded 27 July 2023 and can be viewed on our website here. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our ⁠⁠⁠⁠⁠Knowledge Center⁠⁠⁠⁠⁠. Thank you for listening!

Listen to a captivating and informative conversation aiming to help you master EU compliance, where BSI's Global Head Clinical Compliance Richard Holborow and RQM+'s Senior Vice President of Intelligence and Innovation Amie Smirthwaite come together and address current challenges and provide valuable insights on navigating the complex landscape of EU regulations.

This conversation will:

Richard and Amie at a glance...

Key topics of discussion:

Benefits for listeners:

🎬 In a new eye-opening episode of MedTech Voices, Medical Director Sally Sennitt and VP Jaishankar Kutty, Ph.D. – a true expert on cardiac valves – explore the EU MDR expert panel feedback from a minimally invasive tricuspid valve.

🩺 The submitted data from a single-arm study with a short six-month follow up, was found to be insufficient and lacking in quality and quantity... and not supporting a benefit-risk profile.

You'll learn considerably more from watching (or listening to) the 10-minute clip, but a few points:

1️⃣ The device's benefit-risk profile was not considered positive, highlighting the need for an RCT (Randomized Controlled Trial) comparing it against guideline-led medical therapy. Also, a six-month follow up was deemed not good enough for a CE marking.

2️⃣ The PMCF (Post-Market Clinical Follow-up) plan was underwhelming and raised several concerns. The study design lacked clear endpoints and didn't provide enough insight into what constitutes acceptable reduction in TR.

3️⃣ Regulatory and clinical reasons led the expert panel to conclude that this device is not ready for the market.

This episode serves as a critical reminder for the entire MedTech community to be vigilant about the quality of submissions to notified bodies. We must ensure we uphold the highest standards, especially during this significant juncture for the EU MDR.

This show was recorded 29 June 2023 and can be viewed on our website here⁠⁠. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our ⁠⁠⁠⁠Knowledge Center⁠⁠⁠⁠. Thank you for listening!

This panel discussion was all about the FDA's latest pre-submission guidance, with an emphasis on best practices for Predetermined Change Control Plans (PCCP). As always, we took questions from the audience and answered as many as we could! 

Key points of discussion included:

Don't miss this opportunity to explore the advantages, potential challenges, and optimal approaches to leverage pre-submission meetings and PCCPs. We hope you’ll join our experienced and versatile team as they explore these topics and answer your questions.

Panelists:

Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees.

Thanks for all the warm messages and feedback in response to our first Excellence Spotlight two weeks ago with Eila Pattee, MS, MLS(ASCP), RAC. Now it's time for round two!

🌟 In this latest episode, we're delighted to introduce none other than Vice President of Technical, Jonathan Gimbel, Ph.D. A problem solver through and through, this clip goes deep into what's made Jon successful. We think there are some incredible insights to learn from Jon's journey and apply to your own career.

Questions asked by Jaishankar Kutty, Ph.D.:

❓ Can you walk us through aspects of your educational background and path that enable you to be successful on a day-to-day basis at RQM+ and can you talk about your specific focus areas?

❓ What are some of the specific technical aspects that enable you to be successful on a daily basis?

❓ One you're in the deep end, you have to wallow through the grey and come up with successes. How do equip yourself to do that? What are some of the mental aspects that you recruit to help you be successful?

❓ What are some of your key achievements and what gets you excited on a daily basis?

We hope you enjoy! And we can't share an Excellence Spotlight without saying what RQM+ is all about: the plus is the people.

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📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use ⁠⁠⁠⁠⁠⁠our contact form⁠⁠⁠⁠⁠⁠.

Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees.

At RQM+, 𝐭𝐡𝐞 𝐩𝐥𝐮𝐬 𝐢𝐬 𝐭𝐡𝐞 𝐩𝐞𝐨𝐩𝐥𝐞.

We've been saying it, but now it's time to 𝒔𝒉𝒐𝒘 𝒚𝒐𝒖. 🎥

We're thrilled to unveil a new video series shining a spotlight on the outstanding individuals who help keep our clients moving forward!

🔦 Introducing the Excellence Spotlight series, where we celebrate exceptional talents and showcase the remarkable journeys and achievements of employees. We're starting with Principal, Eila Pattee, MS, MLS(ASCP), RAC.

🏅 We dive into Eila's journey at RQM+ and how she's made a lasting impact in the MedTech industry.

Through this series, we aim to inspire and uplift those who strive for excellence. The plus is the people at RQM+, after all!

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📹 ⁠View and share this clip on LinkedIn.⁠

📲 ⁠Follow RQM+ on LinkedIn.⁠

💼 Check out our open positions.

📚 ⁠See on-demand content in our Knowledge Center.⁠

📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use ⁠⁠⁠⁠⁠our contact form⁠⁠⁠⁠⁠.

🗣️ We're excited to release the fifth installment of our MedTech Voices mini series about 𝐄𝐔 𝐌𝐃𝐑 𝐄𝐱𝐩𝐞𝐫𝐭 𝐏𝐚𝐧𝐞𝐥 𝐅𝐞𝐞𝐝𝐛𝐚𝐜𝐤. If you've been following along, this series is all about sharing perspectives on the feedback (CECP per EU MDR, Article 54) from clinical reviews completed over the last year.
𝘐𝘴 𝘵𝘩𝘦 𝘳𝘦𝘱𝘰𝘳𝘵 𝘥𝘪𝘴𝘤𝘶𝘴𝘴𝘦𝘥 𝘪𝘯 𝘵𝘩𝘪𝘴 𝘤𝘭𝘪𝘱 𝘴𝘦𝘯𝘥𝘪𝘯𝘨 𝘢 𝘣𝘢𝘥 𝘮𝘦𝘴𝘴𝘢𝘨𝘦 𝘵𝘰 𝘮𝘢𝘯𝘶𝘧𝘢𝘤𝘵𝘶𝘳𝘦𝘳𝘴? 🤔
👨‍🏫 Jaishankar Kutty, Ph.D., VP of Intelligence and Innovation, is joined once more by Medical Director 👩‍🏫 Sally Sennitt. This clip focuses on a transcatheter heart valve – likely a balloon-expandable valve – and the report wasn't positive (even troubling). Our experts go into meaningful detail as to why.
Questions covered 👇
1️⃣ What was your overall feeling about this one?
2️⃣ What were some of your takeaways on the panel's comments and what was submitted to them?
3️⃣ What does this mean for manufacturers?
We appreciate you listening!

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📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use ⁠⁠⁠⁠our contact form⁠⁠⁠⁠.