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
Biocytogen and Acepodia Expand Collaboration Through Option-based Evaluation Framework for First-in-Class Bispecific and Dual-Payload ADCs (BsAD2C)9.1.2026 13:00:00 CET | Press release
Expanded collaboration builds on Acepodia and Biocytogen’s recent co-development efforts to evaluate selected bispecific antibody and dual-payload ADC programs Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, SSE: 688796; HKEX: 02315) and Acepodia (6976:TT), today announced that the companies have entered into an option and license agreement designed to enable the structured evaluation of bispecific antibody-drug conjugate (BsADC) programs to further advance the development of dual-payload bispecific antibody-drug conjugates (BsAD2Cs). The agreement grants Acepodia an option to obtain an exclusive worldwide license from Biocytogen for two BsADC programs. Under the terms of the agreement, Biocytogen is eligible to receive an upfront option fee and, upon Acepodia’s exercise of the option, additional payments including option exercise fees, development, regulatory, and commercial milestone payments, as well as royalties on future product sales. The financial terms of the agreem
Blockstream Capital Partners Announces Strategic Acquisition of Derivatives Trading Team from Numeus Group, Leveraging Strategic Partnership with Komainu9.1.2026 11:08:00 CET | Press release
Blockstream Capital Partners (“BCP”) today announced that it has entered into a strategic agreement to acquire a division within Numeus Group’s digital asset trading and investment business. The transaction includes the absorption of select Bitcoin focused trading strategies with a focus on yield generation as well as a ten person derivatives trading team led by Chief Investment Officer Deepak Gulati, a specialist in volatility and derivatives markets. Deepak Gulati, appointed Co-Chief Investment Officer of Blockstream Capital Management alongside Rodrigo Rodriguez, previously served as Global Head of Proprietary Trading at JPMorgan, before founding Argentiere Capital, a multibillion-dollar volatility-focused hedge fund. With a thesis that derivatives would drive Bitcoin and digital asset market maturity, he co-founded Numeus Group in 2021 to develop institutional-grade trading, risk management and market-structure capabilities. Komainu, an existing BCP strategic investment, has played
Autel Unveils Strategic Shift at CES 2026: Building the AI-Powered Infrastructure of Future Cities9.1.2026 10:44:00 CET | Press release
At the Consumer Electronics Show (CES), Autel Energy is presenting its latest AI-driven smart hardware and software systems for the future of intelligent urban operations. This year’s showcase highlights Autel’s shift from AI concept validation to scenario-based engineering deployment, emphasizing closed-loop execution across real-world infrastructure. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260101511436/en/ Autel Energy New Product Debut at CES 2026 Focusing on two key domains — Smart Energy and Smart Inspection — the company is unveiling a range of new products. In Smart Energy, Autel is introducing V2G (Vehicle-to-Grid) AC charger for homes and DC charging solution for fleets, strengthening its multi-tier energy touchpoint strategy from households to commercial operations. Live demonstrations at the booth will feature a smart charging robot showcasing automated plug-in capabilities. In Smart Inspection, Autel will
Allianz and Anthropic Forge Global Partnership to Advance Responsible AI in Insurance9.1.2026 10:00:00 CET | Press release
Anthropic’s safety-first AI meets Allianz's dedication to customer centricity, stakeholder trust, and regulatory excellenceThree focus areas of the partnership: workforce empowerment, operations automation through agentic AI, and regulatory compliance Allianz SE and Anthropic today announced a global partnership to accelerate the adoption of responsible Artificial Intelligence (AI) at Allianz. The collaboration centers on three transformative projects within Allianz Group designed to empower Allianz employees and accelerate operations, while setting new benchmarks for accuracy. “With this partnership, Allianz is taking a decisive step to address critical AI challenges in insurance. Anthropic’s focus on safety and transparency complements our strong dedication to customer excellence and stakeholder trust. Together, we are building solutions that prioritize what matters most to our customers while setting new standards for innovation and resilience,” said Oliver Bäte, CEO of Allianz SE.
MRM Health Secures FDA IND Clearance to Launch its Phase 2b Trial of MH002 in Mild-to-Moderate Ulcerative Colitis9.1.2026 07:00:00 CET | Press release
MH002 is currently the most advanced Live Biotherapeutic Product (LBP) based on a rationally-designed combination of disease specific bacteria (microbial consortia), for the treatment of inflammatory bowel diseases (IBD) STARFISH-UC Phase 2b trial is designed to confirm MH002’s early efficacy signals and favorable safety observed in Phase 2a studies MRM Health NV, a clinical-stage biopharmaceutical company pioneering microbiome-based therapeutics for inflammatory diseases and immune-oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted clearance of its Investigational New Drug (IND) application for its lead program MH002. This enables the initiation of the STARFISH-UC Phase 2b clinical trial in patients with mild-to-moderate ulcerative colitis, marking a significant step forward in the development of next-generation therapies for inflammatory bowel diseases (IBD). About the STARFISH-UC Phase 2b Trial The STARFISH-UC trial is a randomized, double-blind,
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