on 31 August 2022 | By RQM+ Subject Matter Experts
The annual RAPS Convergence is coming soon, and our team is excited to actively contribute to this year’s program with several speaking sessions. We’re covering wide-ranging regulations for medical devices and in vitro diagnostics in the EU and U.S. Here’s a preview of what to...
Read Moreon 27 April 2022 | By RQM+ Subject Matter Experts
State of the art (SOTA) is a key piece of the IVDR puzzle. Like many of the other required elements, it touches multiple sections of your technical documentation and must be consistently addressed throughout.
Read Moreon 23 March 2022 | By RQM+ Subject Matter Experts
Until recently, many IVD manufacturers were able to make changes to the design or intended use of their devices with minimal consequences under IVDD (98/79/EC). With the transition to IVDR and the date of application just around the corner, that time window is quickly closing....
Read Moreon 9 February 2022 | By RQM+ Subject Matter Experts
RQM+ is excited to announce the addition of Dr. Heike Moehlig-Zuttermeister as IVD Vice President Intelligence and Innovation. Heike joins us after nearly eight years at BSI, where she held leadership roles within the IVD team.
Read Moreon 31 January 2022 | By RQM+ Subject Matter Experts
“RQM+ is always the first resource I think of when assistance is needed. In addition I cannot state how grateful I am for your organizations thought leadership and resources/content. It’s best in class!” In 2021, we launched the RQM+ Knowledge Center as your one-stop-shop to...
Read Moreon 17 January 2022 | By RQM+ Subject Matter Experts
While we are happy and relieved for the IVD industry to have an extension to the IVDR transition period, we’re concerned that the announcement may result in a misperception that there is plenty of time to get the work done.
Read Moreon 21 December 2021 | By RQM+ Subject Matter Experts
Under the EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR), every IVD must have a Performance Evaluation Report (PER). PERs consist of three pillars: scientific validity, analytical performance and clinical performance. Collating data to satisfactorily address...
Read Moreon 16 December 2021 | By RQM+ Subject Matter Experts
The next key regulatory milestone for manufacturers with products on the European market is the EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR). A critical stage of IVDR planning is for manufacturers to assess whether they have enough clinical and performance...
Read Moreon 8 November 2021 | By RQM+ Subject Matter Experts
In case you missed it, the latest presentation in our webinar series covers the new requirements under EU MDR and IVDR: the Summary of Safety and Clinical Performance (SSCP) and Summary of Safety and Performance (SSP), respectively. It’s no surprise that manufacturers are...
Read Moreon 19 October 2021 | By RQM+ Subject Matter Experts
Background The COVID-19 pandemic has led to unprecedented challenges for the In Vitro Diagnostic Regulation (IVDR) implementation impacting both manufacturers and key European Union (EU) infrastructure. On one hand, manufacturers were faced with staff shortages impacting their...
Read Moreon 21 September 2021 | By RQM+ Subject Matter Experts
RQM+ is excited to announce the addition of Dr. Andrew Tarnaris as Medical Director. With a background as both a medical doctor and notified body clinical expert, he represents an excellent example of our unique combination of clinical and regulatory experience.
Read Moreon 9 September 2021 | By RQM+ Subject Matter Experts
The introduction of MDR caused a major transformation in the medical device industry. Manufacturers continue to grapple with all elements of compliance, but clinical evaluation presents unique challenges. RQM+ is committed to helping clients navigate these challenges with former...
Read Moreon 2 August 2021 | By RQM+ Subject Matter Experts
THE PROJECT A leading global company offering medical technology, services, and solutions engaged RQM+ to help four business units prepare for the EU Medical Device Regulation (MDR). Specifically, RQM+ is focused on assessing and remediating gaps in MDD technical files and...
Read Moreon 21 June 2021 | By RQM+ Subject Matter Experts
The latest addition to our webinar series covers the biggest challenges in IVDR compliance. With hundreds of MDR submissions under our belts and a number of clients who have already received findings from their IVDR applications, we have learned a lot about the regulation, the...
Read Moreon 1 June 2021 | By RQM+ Subject Matter Experts
Food and Drug Administration (FDA) inspections are stressful, especially if your documentation isn’t audit-ready. Creating and maintaining a compliant design history file (DHF) will help ensure that when the time comes, you’ll be ready for an FDA inspection that results in...
Read Moreon 15 December 2020 | By RQM+ Subject Matter Experts
When to use Post-Market Clinical Follow-up (PMCF) Surveys under the European Union's Medical Device Regulation.
Read Moreon 23 November 2020 | By RQM+ Subject Matter Experts
RQM+ sponsored both RAPS U.S. and Euro Convergence conferences in 2020 and we also led and provided subject matter experts for two panel discussions. Our experts pulled together the highlights from both conferences and summarized them by category for our readers.
Read Moreon 8 May 2020 | By RQM+ Subject Matter Experts
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