Making MedTech Happen with RQM+
Episodes
Ethan Elshoff, Senior Project Manager | Excellence Spotlight
19 Oct 2023
Contributed by Lukas
Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are commit...
Catherine Kang, Principal Consultant | Excellence Spotlight
10 Oct 2023
Contributed by Lukas
Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are commit...
EU MDR Expert Panel Feedback (#9) | MedTech Voices
05 Oct 2023
Contributed by Lukas
🎥 Sally Sennitt and Jaishankar Kutty, Ph.D. are back and looking into the expert panel's insights on a shoulder replacement system; a devic...
Kevin Rowland, Director of R&D | Excellence Spotlight
02 Oct 2023
Contributed by Lukas
Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are commit...
Live! #72 – EU MDR Timelines and Fine Lines: Unraveling Critical Transition Nuances to Gain Compliance
28 Sep 2023
Contributed by Lukas
This show was recorded 28 September 2023 and can be viewed on our website here. To join us live for future shows and ask your own question...
Diane Cox, Principal Consultant | Excellence Spotlight
26 Sep 2023
Contributed by Lukas
Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are commit...
Live! #71 – Material Matters: Navigating Risks and Strategies for Improving Medical Device Safety
22 Sep 2023
Contributed by Lukas
This show was recorded 21 September 2023 and can be viewed on our website here. To join us live for future shows and ask your own questions, ple...
EU MDR Expert Panel Feedback (#8) | MedTech Voices
11 Sep 2023
Contributed by Lukas
🎥 We're starting off the week right with a NEW MedTech Voices 🚨 Join our Medical Director Sally Sennitt and VP of Intelligence and Innovat...
Pooja Roychoudhury, Senior Principal Engineer | Excellence Spotlight
06 Sep 2023
Contributed by Lukas
Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees. 🌟 Today, we’re delighted to ...
Live! #70 – IVDR Class D Devices: Advanced Strategies for Succeeding In a Dynamic Regulatory Environment
01 Sep 2023
Contributed by Lukas
This show was recorded 31 August 2023 and can be viewed on our website here. To join us live for future shows and ask your own questions, please view ...
BONUS Excellence Spotlight with Case Studies — Jon Gimbel, Vice President of Technical
22 Aug 2023
Contributed by Lukas
Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees. 🔦 Today, we're back with a...
EU MDR Expert Panel Feedback (#7) | MedTech Voices
15 Aug 2023
Contributed by Lukas
🎬 In our latest MedTech Voices clip, RQM+ VP of Intelligence and Innovation Jaishankar Kutty, Ph.D. and Medical Director Sally Sennitt delve in...
Amie Smirthwaite's Role in ISO 18969 | MedTech Voices
08 Aug 2023
Contributed by Lukas
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 Se...
Bethany Chung, Principal Regulatory Scientist | Excellence Spotlight
03 Aug 2023
Contributed by Lukas
Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees. 🌟 Today as part of our Excelle...
Live! #69 – Insider Perspectives: Mastering EU Compliance with BSI's Richard Holborow and RQM+'s Amie Smirthwaite
28 Jul 2023
Contributed by Lukas
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 an...
EU MDR Expert Panel Feedback (#6) | MedTech Voices
26 Jul 2023
Contributed by Lukas
🎬 In a new eye-opening episode of MedTech Voices, Medical Director Sally Sennitt and VP Jaishankar Kutty, Ph.D. – a true expert on cardiac va...
Live! #68 – Pre-Submission to Preeminence: Showcasing FDA's Latest Pre-Sub Guidance and Uncovering PCCP Best Practices
25 Jul 2023
Contributed by Lukas
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 v...
Jon Gimbel, Vice President of Technical | Excellence Spotlight
19 Jul 2023
Contributed by Lukas
Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees. Thanks for all the warm messages ...
Eila Pattee, Principal Consultant | Excellence Spotlight
07 Jul 2023
Contributed by Lukas
Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees. At RQM+, 𝐭𝐡𝐞 𝐩𝐥𝐮...
EU MDR Expert Panel Feedback (#5) | MedTech Voices
28 Jun 2023
Contributed by Lukas
🗣️ We're excited to release the fifth installment of our MedTech Voices mini series about 𝐄𝐔 𝐌𝐃𝐑 𝐄𝐱𝐩𝐞𝐫𝐭 𝐏...
EU MDR Expert Panel Feedback (#4) | MedTech Voices
02 Jun 2023
Contributed by Lukas
📢 We're thrilled to unveil our latest MedTech Voices video!This clip is the fourth installment in our 𝐄𝐔 𝐌𝐃𝐑 𝐄𝐱𝐩𝐞𝐫...
Live! #67 – Beyond Indications: Managing Off-Label Use for Safety and Compliance
25 May 2023
Contributed by Lukas
This show was recorded 25 May 2023 and can be viewed on our website here. To join us live for future shows and ask your own questions, ple...
Live! #66 – Pragmatic and Compliant Approaches to Clinical Evidence
28 Apr 2023
Contributed by Lukas
This show was recorded 27 April 2023 and can be viewed on our website here. The website recording has clickable chapters allowing you to instant...
EU MDR Expert Panel Feedback (#3) | MedTech Voices
03 Apr 2023
Contributed by Lukas
Today's new installment of MedTech Voices revisits a series from last year on EU MDR Expert Panel Feedback, where Jaishankar Kutty, Ph.D. and A...
Traversing the Path from CER to PMCF (#2) | MedTech Voices
28 Mar 2023
Contributed by Lukas
Our experts are back for the final MedTech Voices episode in our 𝗧𝗿𝗮𝘃𝗲𝗿𝘀𝗶𝗻𝗴 𝘁𝗵𝗲 𝗣𝗮𝘁𝗵 𝗳𝗿𝗼𝗺...
Traversing the Path from CER to PMCF (#1) | MedTech Voices
27 Mar 2023
Contributed by Lukas
Our MedTech Voices 10 minutes or less video/audio series, returns with the first of two new clips in a mini series entitled Traversing the Path from C...
Live! #65 – How AI is Revolutionizing MedTech: Current and Future Applications
24 Mar 2023
Contributed by Lukas
This show was recorded 23 March 2023 and can be viewed on our website here. To join us live for future shows and ask your own questions, please view a...
Live! #64 – The Evolving Biocompatibility Landscape: Staying Ahead of Regulatory Requirements
17 Feb 2023
Contributed by Lukas
This is audio from RQM+ Live! #64, recorded 16 February 2023. To join us live for future shows and ask your own questions, please view and sign up for...
Live! #63 – Start 2023 Right: Smart and Savvy Tips from Former Regulators and Notified Bodies
27 Jan 2023
Contributed by Lukas
This is audio from RQM+ Live! #63, recorded 26 January 2023. To join us live for future shows and ask your own questions, please view and sign up for ...
Proactive PMCF Data with Economy and Expediency (#3) | MedTech Voices
23 Jan 2023
Contributed by Lukas
Our PMCF trio is back with another #MedTechVoices clip. Mini series: ⚙️ 𝐏𝐫𝐨𝐚𝐜𝐭𝐢𝐯𝐞 𝐏𝐌𝐂𝐅 𝐃𝐚𝐭𝐚 𝐰...
Proactive PMCF Data with Economy and Expediency (#2) | MedTech Voices
18 Jan 2023
Contributed by Lukas
Our PMCF trio is back with another #MedTechVoices clip! Mini series: ⚙️ 𝐏𝐫𝐨𝐚𝐜𝐭𝐢𝐯𝐞 𝐏𝐌𝐂𝐅 𝐃𝐚𝐭𝐚 𝐰...
MDCG Proposal for EU MDR Postponement – The Latest on What's Next
06 Jan 2023
Contributed by Lukas
#MedTechVoices 🗣️ continues in 2023 with Vice President of Intelligence & Innovation, Jaishankar Kutty, who shares additional thoughts on the...
Proactive PMCF Data with Economy and Expediency (#1) | MedTech Voices
13 Dec 2022
Contributed by Lukas
#MedTechVoices continues with the first episode of a brand new mini series: Proactive PMCF Data with Economy and Expediency (#1). This series is about...
EU MDR Postponed – What We Know Now and What's Next
09 Dec 2022
Contributed by Lukas
#MedTechVoices 🗣️ continues with Vice President of Intelligence & Innovation, Jaishankar Kutty, who shares his thoughts on the EU MDR postpon...
EU MDR Expert Panel Feedback (#2) | MedTech Voices
01 Dec 2022
Contributed by Lukas
We're back with our second ever episode of #MedTechVoices 🗣️ #MedTechVoices is our ongoing video/audio series that provides an avenue for our sea...
EU MDR Expert Panel Feedback (#1) | MedTech Voices
17 Nov 2022
Contributed by Lukas
We'd like to introduce you to something new: #MedTechVoices 🗣️ #MedTechVoices will be our ongoing video/audio series that provides an avenue for ...
Live! #62 – Standards and State of the Art (SOTA)
08 Nov 2022
Contributed by Lukas
This is audio from RQM+ Live! #62, recorded 3 November, 2022. To join us live for future shows and ask your own questions, please view and sign up for...
Live! #61 – Medical Device Software: Top Deficiencies and Requests for Additional Info from FDA and Notified Bodies
14 Oct 2022
Contributed by Lukas
This is audio from RQM+ Live! #61, recorded 13 October, 2022. To join us live for future shows and ask your own questions, please view and sign up for...
Live! #60 – RAPS Convergence Takeaways: RQM+ event speakers share their biggest surprises and learnings
26 Sep 2022
Contributed by Lukas
This is audio from RQM+ Live! #60, recorded 22 September, 2022. To join us live for future shows and ask your own questions, please view and sign up f...
Live! #59 – Clinical Evidence vs. Clinical Performance – A Deep Dive into MDCG 2022-2 and Notified Body Expectations
22 Jul 2022
Contributed by Lukas
This is audio from RQM+ Live! #59, recorded 21 July, 2022. To join us live for future shows and ask your own questions, please view and sign up for up...
Live! #58 –Regulatory Landscape of Companion Diagnostics (CDx) in the EU
15 Jul 2022
Contributed by Lukas
This is audio from RQM+ Live! #58, recorded 14 July, 2022. To join us live for future shows and ask your own questions, please view and sign up for up...
Live! #57 – FDA Appeals Process (featuring panelists from Linear Health and DuVal & Associates, PA)
30 Jun 2022
Contributed by Lukas
This is audio from RQM+ Live! #57, recorded 30 June, 2022. To join us live for future shows and ask your own questions, please view and sign up for up...
Live! #56 – IVDR: A Notified Body Perspective (featuring Marta Carnielli of TÜV SÜD)
13 Jun 2022
Contributed by Lukas
This is audio from RQM+ Live! #56, recorded 9 June, 2022. To join us live for future shows and ask your own questions, please view and register for up...
Live! #55 – Is your labeling thrice as big as your device yet?
24 May 2022
Contributed by Lukas
This is the audio from RQM+ Live! #55, recorded 19 May, 2022. Listen and learn why the MDR / IVDR labeling requirements are a great opportunity to sta...
Live! #54 – Implications of FDA Adopting ISO 13485 and How to Prepare
24 May 2022
Contributed by Lukas
This is the audio from RQM+ Live! #54, recorded 5 May, 2022. Listen as our panelists provide insight on the changes in the new requirements and what s...
Live! #53 – Part 2: PSURs – Ready, Set, Go!
26 Apr 2022
Contributed by Lukas
This is the audio from RQM+ Live! #53, recorded 21 April, 2022. Please note we have not listed the questions asked during the show in this description...
Live! #52 – Part 2: What’s new in the world of biocompatibility for medical devices?
11 Apr 2022
Contributed by Lukas
This is the audio from RQM+ Live! #52, recorded 7 April, 2022. During our previous show on this topic we were flooded with questions from viewers (whi...
Live! #51 – Leveraging your medical directors and clinicians for successful regulatory submissions
29 Mar 2022
Contributed by Lukas
This is the audio from RQM+ Live! #51, recorded 24 March, 2022. In this session, our panel of clinicians (including a neurosurgeon and anesthesi...
Live! #50 – IVDR Notified Body Application Process
14 Mar 2022
Contributed by Lukas
This is the audio from RQM+ Live! #50, recorded 10 March, 2022. A "notified body application" for IVDR CE certification can feel like 510(k) submissio...
RQM+ Live! #49 — PSURs – Ready, Set, Go!
01 Mar 2022
Contributed by Lukas
This is the audio from RQM+ Live! #49, recorded 24 February, 2022. The session description below has been abbreviated significantly in order to list t...
RQM+ Live! #48 — Part 2: Sustaining EU MDR and IVDR certification in the post-market phase - What will it take?
15 Feb 2022
Contributed by Lukas
This is the audio from RQM+ Live! #48, recorded 10 February, 2022. The session description below has been abbreviated in order to list the questions. ...
RQM+ Live! #47 — Have we been looking at EU MDR equivalence requirements all wrong?
31 Jan 2022
Contributed by Lukas
This is the audio from RQM+ Live! #47, recorded 27 January, 2022. The session description below has been abbreviated in order to list the questions. T...
RQM+ Live! #46 — Year-end Review and 2022 Outlook on FDA Submissions
18 Jan 2022
Contributed by Lukas
This is the audio from RQM+ Live! #46, recorded 13 January, 2022. As we enter 2022, we'd like to reflect on what's happened over the past year in...
RQM+ Live! #45 — What’s new in the world of biocompatibility for medical devices?
06 Jan 2022
Contributed by Lukas
This is the audio from RQM+ Live! #45, originally recorded 16 December, 2021. Generating evidence of biocompatibility continues to be a significant ch...
RQM+ Live! #44 — Success Stories of PMCF Surveys: Strategy and Execution
03 Dec 2021
Contributed by Lukas
The RQM+ team has collected PMCF data from surveys on thousands of patients and charts on hundreds of devices, and we're excited to share our case stu...
RQM+ Live! #43 — Spinal Implantable Device Classification Changes Resulting from MDCG 2021-24
11 Nov 2021
Contributed by Lukas
This is the audio from RQM+ Live! #43, originally recorded 11 November, 2021. MDCG 2021-24: Guidance on Classification of Medical Devices was released...
Live! #41 — Best Practices for Optimizing PMCF and Avoiding NB Findings
15 Oct 2021
Contributed by Lukas
This is the audio from RQM+ Live! #41, originally recorded 14 October, 2021. Your post-market surveillance (PMS) system complying to the EU MDR was pu...
Live! #40 — When should we throw the least burdensome flag or appeal an FDA decision?
01 Oct 2021
Contributed by Lukas
This is the audio-only version of RQM+ Live! #40, originally recorded 30 September, 2021. This has been a very common question from device manufacture...
Live! #39 — Sustaining EU MDR and IVDR certification in the post-market phase - What will it take?
27 Aug 2021
Contributed by Lukas
This is the audio-only version of RQM+ Live! #39, originally recorded 26 August, 2021. The climb to MDR certification is well underway for device manu...
Live! #38 — Best Practices in Site Transfer (or Consolidation)
23 Jul 2021
Contributed by Lukas
This is the audio-only version of RQM+ Live! #38, originally recorded 22 July, 2021. Market consolidation and acquisitions along with the relocation o...
Live! #37 — U.S. FDA Pathways for Innovative Devices
18 Jun 2021
Contributed by Lukas
This is the audio-only version of RQM+ Live! #37, originally recorded June 17, 2021. The U.S. FDA provides multiple pathways to expedite regulatory cl...
Event Recording — FDA Submissions in 2021: How's it going?
09 Jun 2021
Contributed by Lukas
This is the audio recording from our panel discussion at the MassMEDIC Mid-Year FDA Update event held on April 20, 2021. You can watch the panel discu...
Live! #36 — Types of EU MDR Clinical Evidence Gaps and Best Practice Solutions - Part 2!
03 Jun 2021
Contributed by Lukas
This is the audio-only version of RQM+ Live! #36, originally recorded June 3, 2021. We're back for part two! With so many questions we couldn't addres...
Live! #35 — Preparing for PSURs
20 May 2021
Contributed by Lukas
This is the audio-only version of RQM+ Live! #35, originally recorded May 20, 2021. PSUR - Periodic Safety Update Report - is a new report required by...
Live! #34 — Optimizing Technical Documentation to Reduce Notified Body Review Time and Questions (Devices & IVDs)
06 May 2021
Contributed by Lukas
This is the audio-only version of RQM+ Live! #34, originally recorded May 6, 2021. We all have the same goals when submitting technical documentation ...
Live! #33 — Types of EU MDR Clinical Evidence Gaps and Best Practice Solutions
23 Apr 2021
Contributed by Lukas
This is the audio-only version of RQM+ Live! #33, originally recorded April 22, 2021. "Insufficient clinical evidence" is the most popular and arguabl...
Live! #32 — What if I'm not ready for EU MDR on May 26, 2021?
08 Apr 2021
Contributed by Lukas
This is the audio-only version of RQM+ Live! #32, originally recorded April 8, 2021. The MDR Date of Application is just around the corner, and there ...
Live! #31 — Biological Equivalence Demystified
26 Mar 2021
Contributed by Lukas
This is the audio-only version of RQM+ Live! #31, originally recorded March 25, 2021. In connection with biological equivalence, the MDR states, “th...
Live! #30 — IVD Intended Purpose Statements – Defining for Success
11 Mar 2021
Contributed by Lukas
This is the audio-only version of RQM+ Live! #30, originally recorded March 11, 2021. The first and arguably most critical step in the IVDR implementa...
Live! #29 — The surprising true cost of submitting non-compliant technical documentation to notified bodies
25 Feb 2021
Contributed by Lukas
This is the audio-only version of DEVICE LOVE Live! #29, originally recorded February 25, 2021. There has been plenty of discussion regarding what "go...
Live! #28 — Overcoming Challenges with Integrating PMS, CERs/PERs and Risk Management under EU MDR and IVDR
12 Feb 2021
Contributed by Lukas
This is the audio-only version of DEVICE LOVE Live! #28, originally recorded February 11, 2021. The MDR and IVDR have significantly increased requirem...
Live! #27 — 2021 Outlook on FDA Submissions
28 Jan 2021
Contributed by Lukas
This is the audio-only version of DEVICE LOVE Live! #27, originally recorded January 28, 2021. We’re almost one month into 2021... and we're sure ev...
Live! #26 — What is the Biggest EU MDR or IVDR Question You Need to be Answered?
15 Jan 2021
Contributed by Lukas
This is the audio-only version of DEVICE LOVE Live! #26, originally recorded January 14, 2021. In this unique episode of DEVICE L❤️VE Live!, the f...
Live! #25 — Is ISO 14971:2019 required under MDR/IVDR?
21 Dec 2020
Contributed by Lukas
This is the audio-only version of DEVICE LOVE Live! #25, originally recorded 17 December 2020. ISO 14971:2019 is not yet harmonized to the EU MDR/IVDR...
Live! #24 — Generating Sufficient Clinical Evidence for IVDs
04 Dec 2020
Contributed by Lukas
This is the audio-only version of DEVICE LOVE Live! #24, originally recorded 3 December 2020. The IVDR has detailed requirements for performance evalu...
Live! #23 — Make real world evidence work for you: How to leverage real world data in the US and EU
24 Nov 2020
Contributed by Lukas
This is the audio-only version of DEVICE LOVE Live! #23, originally recorded 19 November 2020. As defined by the FDA, Real-world data (RWD)&...
Live! #22 — Summary of Safety and Clinical Performance
06 Nov 2020
Contributed by Lukas
This is the audio-only version of DEVICE LOVE Live! #22, originally recorded 5 November 2020. The Summary of Safety and Clinical Performance or "SSCP"...
Live! #21 — Avoid Audit Findings! Collecting Relevant Data for PMCF Surveys
23 Oct 2020
Contributed by Lukas
This is the audio-only version of DEVICE LOVE Live! #21, originally recorded 22 October 2020. Will collecting the data be successful? One of the bigge...
Live! #20 — Commercializing Medical Devices in a Post-Brexit World
12 Oct 2020
Contributed by Lukas
This is the audio-only version of DEVICE LOVE Live! #20, originally recorded 8 October, 2020. Although the date of Brexit has passed us, the UK contin...
Live! #19 — The most popular PMCF and PMPF questions from our clients
29 Sep 2020
Contributed by Lukas
This is the audio-only version of DEVICE LOVE Live! #19, originally recorded 24 September, 2020. There's a lot of uncertainty in the industry around m...
Live! #17 — Periodic Safety Update Report: How do you write it without guidance?
11 Sep 2020
Contributed by Lukas
This is the audio-only version of DEVICE LOVE Live! #17, originally recorded September 10, 2020. The Periodic Safety Update Report or "PSUR" is requir...
Live! #16 — Creating Performance Evaluation Plans and Reports under the IVDR
31 Aug 2020
Contributed by Lukas
This is the audio-only version of DEVICE LOVE Live! #16, originally recorded August 27, 2020. Performance Evaluation Plans (PEPs) and Reports (PERs) a...
Live! #15 — When to use the FDA Q-Submission (Pre-Sub) Program
14 Aug 2020
Contributed by Lukas
This is the audio-only version of DEVICE LOVE Live! #15, originally recorded August 13, 2020. The rules of requests for feedback and pre-submission me...
Live! #14 — Is your device a Well-Established Technology (WET) under EU MDR?
31 Jul 2020
Contributed by Lukas
This is the audio-only version of DEVICE LOVE Live! #14, originally recorded July 30, 2020. Based on the amount of questions we're receiving around th...
Live! #13 — Is this software application a medical device?
17 Jul 2020
Contributed by Lukas
This is the audio-only version of DEVICE LOVE Live! #13, originally recorded July 16, 2020. It can be difficult to keep software clear of being classi...
Live! #12 — Tips and Tricks for a Smooth 510(k) Process
06 Jul 2020
Contributed by Lukas
This is the audio-only version of DEVICE LOVE Live! #12, originally recorded July 2nd, 2020. Whether you're on your first 510(k) submission at a start...
Live! #11 — I don't have clinical data for my device. What are my options for fulfilling the sufficient clinical evidence requirements under EU MDR?
25 Jun 2020
Contributed by Lukas
This is the audio-only version of DEVICE LOVE Live! #11, originally recorded June 25th, 2020. Demonstrating "sufficient clinical evidence" is now a cl...
Live! #10 — Transition to IVDR: How far along should we be?
18 Jun 2020
Contributed by Lukas
This is the audio-only version of DEVICE LOVE Live! #10, originally recorded June 18th, 2020. The clock is ticking down to the IVDR date of applicatio...
Live! #9 — Experiences with the FDA 3rd Party 510(k) Review Program
11 Jun 2020
Contributed by Lukas
This is the audio-only version of DEVICE LOVE Live! #9, originally recorded June 11th, 2020. The FDA 3rd Party Review program has been in use for many...
Live! #8 — FDA Trends: Inspections and Submissions
04 Jun 2020
Contributed by Lukas
This is the audio-only version of DEVICE LOVE Live! #8, originally recorded June 4th, 2020. With the EU being on the hot seat lately, and all eyes and...
Live! #7 — Getting Legacy Device Risk Files Ready for EU MDR / ISO 14971:2019
28 May 2020
Contributed by Lukas
This is the audio-only version of DEVICE LOVE Live! #7, originally recorded May 28th, 2020. Under EU MDR, notified bodies are required to look at ever...
Live! #6 — PMCF Process in Action: Best Practices for MDR Compliance
22 May 2020
Contributed by Lukas
This is the audio-only version of DEVICE LOVE Live! #6, originally recorded May 21st, 2020. Join us for an open discussion with former FDA and Notifie...
Live! #5 — Chatting with Former FDA and Notified Body Representatives
15 May 2020
Contributed by Lukas
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 Notifie...
Live! #4 — Best Practices for Easing the Burden of a Medical Device Remediation Program
12 May 2020
Contributed by Lukas
This is the audio-only version of DEVICE LOVE Live! #4, originally recorded May 8th, 2020. Remediation programs at medical device companies are very h...
Live! #3 — Recent MDD and MDR Audit Findings: What are we seeing?
12 May 2020
Contributed by Lukas
This is the audio-only version of DEVICE LOVE Live! #3, originally recorded May 1st, 2020. Notified Body auditors have increased scrutiny as promised ...
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
12 May 2020
Contributed by Lukas
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 auth...
Live! #1 — Moving medical device manufacturing out of China
12 May 2020
Contributed by Lukas
This is the audio-only version of DEVICE LOVE Live! #1, originally recorded April 17th, 2020. The medical device industry’s reliance on China for su...