Making MedTech Happen with RQM+

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. On 26 August, 2021, we conducted a Live! show on the topic of sustaining EU MDR and IVDR, and we were flooded with audience questions... which we loved! We ran out of time and promised a round two to give everyone a chance to pose their questions to...

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. The equivalence requirements of MDR Article 61 Sections 4 and 5 have been interpreted conservatively thus far by notified bodies and industry. It's simple – for Class III and implantable devices, the manufacturer cannot leverage data from an equivale...

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 the world of FDA and medical devices. We'll be sharing our insights to how the Agency did in 2021 and a recap of the most important, cross-cutting regulatory changes. Additionally, we'll provide a forecast of what we can expect in 2022. T...

This is the audio from RQM+ Live! #45 , originally recorded 16 December, 2021. Generating evidence of biocompatibility continues to be a significant challenge to regulatory submission success and product-to-market timelines. And global requirements and interpretations continue to evolve, further increasing the challenge. In this show, we will discuss the changes to standards in recent years, what’...

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 studies. In this Live! show we will dive into our PMCF survey successes and discuss the ways that surveys have significantly helped manufacturers maintain label indications by providing a process for collecting data to support all claims, indications, a...

This is the audio from RQM+ Live! #43 , originally recorded 11 November, 2021. MDCG 2021-24: Guidance on Classification of Medical Devices was released in October 2021, clarifying spinal implantable medical device classifications. Related MDR language published in 2017 left room for interpretation. In the absence of official guidance over the past 4+ years of transitioning to the MDR, manufacturer...

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 put into place in May 2021. How is it going? Now months later, there are an abundance of issues and questions!  This panel discussion provides a unique opportunity to learn from the experiences of seasoned experts as they share PMCF successes and...

This is the audio-only version of RQM+ Live! #40 , originally recorded 30 September, 2021. This has been a very common question from device manufacturers since FDA issued guidance on “least burdensome” almost 20 years ago. FDA defines “least burdensome” to be the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient manner...

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 manufacturers. It's been quite an undertaking, but with careful planning, budgeting and execution, it has and will lead to continued successful commercialization of medical devices and IVD’s in the EU. However, achieving certification is just the beginn...

This is the audio-only version of RQM+ Live! #38 , originally recorded 22 July, 2021. Market consolidation and acquisitions along with the relocation of design centers and manufacturing facilities to OUS locations are resulting in what appears to be a continuous cycle of site transfers for medical device companies. RQM+ is a strategic partner to these companies, providing all things regulatory and...

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 clearance/approval for much needed innovative devices. As a regulatory consultancy, we've had the opportunity to support manufacturers achieve successful entry to the market using these various pathways. We're very excited about FDA's recently release...

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 discussion on our website here . RQM+ is an Associate Member of MassMEDIC and is sponsoring their FDA series this year (look for another event in December). We're always delighted to collaborate with the team at MassMEDIC. FDA Submissions in 2021: How's i...

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 address during our April 22, 2021 show on this topic ( available on demand ), we needed to come back a second time. This is clearly a topic many of you are interested in and we want to help, so here's a second chance to learn from RQM+ subject matter expe...

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 the EU MDR and IVDR. Device manufacturers must have their PSURs ready for review in May 2022 for Class IIb and III devices, and May 2023 for Class IIa devices. It may feel like there is plenty of time to prepare and no need to start yet, but it's i...

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 to the notified body for review: Minimize questions Minimize deficiencies Achieve certification There are many strategies to improve your odds, and this panel of experts knows them well. We'll discuss the easy solutions, such as simply using termino...

This is the audio-only version of RQM+ Live! #33 , originally recorded April 22, 2021. "Insufficient clinical evidence" is the most popular and arguably the most difficult notified body deficiency to address. This finding comes in many shapes and sizes, as do the possible solutions. In this Live! episode, our panel of experts will discuss the following and more: What types of clinical evidence gap...

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 is no indication of another delay coming. If some or all of your products won't be ready in time, you may be starting to panic. In this show we'll start by debunking the bad ideas that we've heard. Here are some examples: No, you should not reclassi...

This is the audio-only version of RQM+ Live! #31 , originally recorded March 25, 2021. In connection with biological equivalence, the MDR states, “the device uses the same materials or substances in contact with the same human tissues or body fluids for a similar kind and duration of contact and similar release characteristics of substances, including degradation products and leachables.” The inte...

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 implementation process is determining if you have a compliant intended purpose statement . This has proven to be challenging, even for legacy devices, and has already resulted in notified body findings for manufacturers who are getting a head start over other...

This is the audio-only version of DEVICE LOVE Live! #29 , originally recorded February 25, 2021. There has been plenty of discussion regarding what "good enough " means with respect to compliance to the MDR and IVDR. There are many new requirements, and the EU is enforcing much stricter interpretations of requirements that existed under the Directives. A recurring theme is that there will be no “g...

This is the audio-only version of DEVICE LOVE Live! #28 , originally recorded February 11, 2021. The MDR and IVDR have significantly increased requirements for clinical, regulatory, and post-market surveillance documentation. To make it even more challenging, there are overlapping requirements resulting in the need for consistent information across a variety of plans and reports. The integration o...

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 everyone's hoping for a much better year than the last! With a focus on FDA regulatory submissions, we would like to provide context for what occurred in 2020 and provide forward-looking guidance for expectations in 2021. Will 2021 be smooth sailing or...

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 focus turns to Dr. Amie Smirthwaite, Head of Clinical Regulatory Affairs at RQM+, as she answers questions from our recent EU MDR and IVDR email survey. Amie will be covering a multitude of areas, including legacy products, CERs, PMCF, PSURs, and notifie...

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, however, BSI has declared that it is the state of the art and is issuing findings against it in MDR audits. Regardless, it is anticipated the 2019 revision will be harmonized to the regulations and therefore, we recommend manufacturers begin the t...

This is the audio-only version of DEVICE LOVE Live! #24 , originally recorded 3 December 2020. The IVDR has detailed requirements for performance evaluation. The new performance evaluation report comprises three separate requirements: scientific validity, analytical validity and clinical evaluation. The majority of in-vitro diagnostic devices were self-certified in the EU prior to the IVDR. Their...