PA-RQM+
RQM+, a leading MedTech service provider, is proud to announce the launch of the Fern.ai Smart Authoring module. The groundbreaking Fern.ai platform now includes Smart Authoring in addition to Systematic Literature Review. Together, these modules are set to transform the landscape of regulatory documentation for MedTech, enhancing compliance, accuracy, and efficiency.
As the MedTech sector evolves, regulatory demands grow increasingly complex. Fern.ai's Smart Authoring module is designed to meet these challenges head-on, offering an intelligent solution that automates and streamlines the creation, management, readiness, and ongoing maintenance of regulatory documents.
Key Features and Benefits:
- Single Source of Truth: Smart Keys and product profiles provide a single source of truth with version control and common terminology and style
- Template Management and Alignment: Readily update content within the product profile and populate product information across templates automatically
- Dynamic Linking Across Documents: Smart Keys readily adapts to content changes and enables collaboration across authors
- Enhance Team Collaboration: Provide access to cross-functional users for in-platform comments and editing
- Streamline Literature Reviews: Conduct your literature reviews in Fern.ai and add outputs directly into your product documentation via Smart Authoring integration
Fern.ai Smart Authoring addresses the critical need of speed and accuracy for regulatory documents in preparation for submissions, helping manufacturers reduce time-to-market for their innovative products. By automating repetitive tasks and ensuring consistency across regulatory documents, the platform allows teams to focus on higher-value activities, ultimately driving greater efficiency and innovation within the organization.
"Fern.ai’s Smart Authoring module represents a significant leap forward for the medical device industry," said John Potthoff, CEO of RQM+. "By harnessing the power of AI and automation, we're not only simplifying the creation, management, and maintenance of regulatory documentation but more importantly, it enables manufacturers to bring life-saving devices to market faster and with greater confidence. This platform is a game-changer for regulatory affairs professionals and the MedTech industry as a whole."
With the launch of Fern.ai’s Smart Authoring module, RQM+ reaffirms its commitment to innovation and excellence as a MedTech service provider. Based on the proven AI expertise of our instrumental development partner Giotto.ai, the Smart Authoring module paves the way for a more efficient and compliant future in MedTech.
For more information about Fern.ai Smart Authoring, visit Fern.ai.
About RQM+
RQM+ is a global MedTech service provider focused on accelerating compliance and market success. Through our unparalleled expertise and industry knowledge, we deliver specialized solutions and expedite the journey along the full product lifecycle for Med Device and IVD companies, from concept to commercialization to post-market.
Our portfolio of services enables the delivery of end-to-end solutions across the complete med device product lifecycle, with our:
- Regulatory and Quality Consulting
- Lab Services (Jordi Labs)
- Clinical Trials
- Reimbursement
- Technology Solutions
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240520880946/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
GeologicAI Announces Acquisition of Lumo Analytics to Complete Its Integrated Sensor Suite Across Critical Minerals and Rare Earth Elements17.12.2025 17:53:00 CET | Press release
GeologicAI, the global leader in High-Resolution Decision Engineering for the critical minerals sector, today announced its acquisition of Lumo Analytics, a provider of the most compact and efficient Laser-Induced Breakdown Spectroscopy (LIBS) scanner in the market. LIBS is a rapid, non-destructive technique that uses a high-energy laser pulse to vaporize a tiny spot on a rock, creating a short-lived plasma which emits light unique to the elements present when it cools. This spectral “fingerprint” provides immediate chemical information about the material. For the mining sector, this means faster geochemical insights directly at the source, enabling more efficient exploration and resource evaluation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251217715846/en/ The transaction firmly cements GeologicAI’s position as the only truly comprehensive and integrated source of sensor data for the critical minerals industry. Buildi
Incyte Announces European Commission Approval of Minjuvi® (tafasitamab) for the Treatment of Relapsed or Refractory Follicular Lymphoma17.12.2025 17:20:00 CET | Press release
Minjuvi® (tafasitamab) in combination with lenalidomide and rituximab is the first CD19- and CD20-dual-targeted immunotherapy combination regimen approved for eligible patients in Europe with relapsed or refractory FLPatients with relapsed or refractory FL achieved significantly improved progression-free survival with Minjuvi in combination with rituximab and lenalidomide in the Phase 3 inMIND registration trialIn Western countries, including Europe, relapsed or refractory FL affects 2-4 out of every 100,000 people1 Incyte (Nasdaq:INCY) today announced that the European Commission (EC) has approved Minjuvi® (tafasitamab) in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one line of systemic therapy. "The EC approval of Minjuvi addresses a critical need, bringing a new, first-of-its-kind, chemotherapy-free option to patients in Europe with relapsed or refractory FL,” said Bi
Rigaku Launches ONYX 3200, a Metrology Instrument for Semiconductor Manufacturing17.12.2025 16:00:00 CET | Press release
Enables complete metal inspection for all processes from chip wiring to advanced packaging on a single platform Rigaku Corporation, a global solution partner in X-ray analytical systems and a group company of Rigaku Holdings Corporation (headquarters: Akishima, Tokyo; CEO: Jun Kawakami; hereinafter “Rigaku”) announced the launch of the ONYX 3200, a new semiconductor metrology system to measure film thickness, composition and bump* structures for wafer-level processes. The system is engineered to help manufacturers stabilize quality and increase yield in the metal-wiring formation (back-end-of-line (BEOL)) and packaging processes of semiconductor chips. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251216597402/en/ ONYX 3200 Due to accelerating demands for AI, high-performance computing, data centers, mobile devices, and other devices, chip wiring and interconnect structures have grown increasingly delicate and complex. As a
Taylor Wessing Diversifies Its International Strategy17.12.2025 15:05:00 CET | Press release
International law firm Taylor Wessing is set to diversify its strategy within its international alliance, in order to push international growth and innovation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251217415857/en/ Dr. Oliver Bertram, Global Co-Chair at Taylor Wessing The English part of the partnership is seeking a merger with US law firm Winston & Strawn and would – depending on a corresponding partner decision, which is still pending – leave the Taylor Wessing alliance at the end of April 2026. Both parties wish to continue their successful joint international client work unchanged. Therefore, collaboration between Taylor Wessing and future Anglo-American firm Winston Taylor will continue seamlessly based on a cooperation agreement, ensuring that clients will not experience any change in their collaboration with Taylor Wessing. With the firm’s new open strategy, Taylor Wessing equally meets the strategic requirem
ISACA to Lead Global Credentialing for CMMC Cybersecurity Framework as International Cyber Readiness Standards Rise17.12.2025 15:00:00 CET | Press release
ISACA appointed to certify professionals assessing organisations against the US Department of War’s (DoW) Cybersecurity Maturity Model Certification (CMMC) programme.New requirements mean that all global businesses supplying to US DoW will need to be compliant with this framework, impacting over 200,000 organisationsAppointment supports global demand for consistent, verifiable cyber maturity amid escalating cyber threats and growing assessor shortages.The Cyber AB remains the official accreditation body for the CMMC programme, authorizing the CAICO and other CMMC ecosystem parties As cyber threats escalate and governments raise expectations around operational resilience, ISACA has been appointed to lead the global credentialing programme for the U.S. DoW’s Cybersecurity Maturity Model Certification (CMMC) program. The appointment positions ISACA – the international association for cybersecurity, audit and digital trust – as the exclusive CMMC Assessor and Instructor Certification Organ
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom