Business Wire

RQM+™ Launches Fern.ai™ Smart Authoring Module for MedTech

Share

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.

Contact information

Media
Ronnie Mahofski, +1 (412) 816-8105, rmahofski@rqmplus.com

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.com

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

Carestream Secures Crucial Business Partner Agreement in Peru17.6.2024 18:14:00 CEST | Press release

Carestream Health recently secured an agreement with Distribuidora Diagnostica Medica SAC (DMD), a leading distributor of radiology solutions in Peru, to convert the latter’s customers and install base to Carestream products. Additionally, under the terms of the agreement, DMD will become an exclusive Carestream distributor in the region. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240617561378/en/ Carestream DRYVIEW 5700C (Photo: Business Wire) As part of the deal, DMD purchased 80 DryView printers, which together have a projected print volume of more than 60,000 square feet in 2024 and over 100,000 square feet in 2025 and beyond. “We are excited to be joining forces with a strong organization like DMD,” said Miguel Nieto, Carestream’s Director of the Americas Region & General Manager of LATAM Consumables Business. “Not only are they one of the leading providers in Peru, but they have a strong track record of taking care

Cognite Atlas AI™ Delivers Specialized Industrial Agents, Virtual Employees Tailored to Provide Domain-Specific Insights and Automate Complex Industrial Tasks17.6.2024 15:00:00 CEST | Press release

Cognite, the globally recognized authority in Data and AI for industry, today announced Cognite Atlas AI™, an industrial agent workbench that extends Cognite’s Industrial DataOps platform, Cognite Data Fusion®. This strategic offering is a culmination of Cognite’s extensive Industrial DataOps and innovative generative AI capabilities. Cognite Atlas AI’s low-code industrial agent builder will enable industrial organizations to use generative AI to carry out more complex operations with greater accuracy, including workflow automation and decision-making support, accelerating efficiencies that can generate tens of millions of dollars in business impact. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240613136987/en/ Cognite Atlas AI enables low-code development of AI agents that increase the accuracy of industrial AI, accelerate efficiencies, and drive business impact (Graphic: Cognite) Cognite Atlas AI provides domain-specific

Takeda Announces Phase 3 Topline Results for Soticlestat (TAK-935) in Patients with Dravet Syndrome and Lennox-Gastaut Syndrome17.6.2024 12:45:00 CEST | Press release

Takeda (TSE:4502/NYSE:TAK) today announced topline data from its SKYLINE and SKYWAY studies. SKYLINE (TAK-935-3001) was a multicenter, randomized, double-blind Phase 3 study that evaluated soticlestat (TAK-935) plus standard of care versus placebo plus standard of care in patients with refractory Dravet syndrome (DS).1 Soticlestat narrowly missed the primary endpoint of reduction from baseline in convulsive seizure frequency as compared to placebo (p-value = 0.06). Among the six key secondary endpoints, soticlestat showed clinically meaningful and nominally significant results in the responder rate, measures of caregiver and clinician global impression of improvement, and seizure intensity and duration scales over the 16-week treatment period (all p-values ≤ 0.008). SKYWAY (TAK-935-3002) was a multicenter, randomized, double-blind Phase 3 study that evaluated soticlestat plus standard of care versus placebo plus standard of care in patients with refractory Lennox-Gastaut syndrome (LGS)

Dubai becomes the world metropolis for artificial intelligence17.6.2024 11:13:00 CEST | Press release

Dubai is increasingly becoming a global center for artificial intelligence. To this end, the metropolis of the day after tomorrow on the Gulf has pledged to train one million people in AI prompting over the next three years with Dubai Future Foundation overseeing the AI prompt program.. It is the first program of its kind in the world. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240613025960/en/ Omar Al Olama, the UAE´s Minister of State for AI, Digital Economy, and Remote Work Applications. (Photo: Business Wire) “We want to be the most future-ready city and continue to prepare for the AI era by developing expertise and skills that support global technological change and put Dubai at the forefront of innovation,” said the Chairman of the Board of Trustees of the Dubai Future Foundation (DFF), Crown Prince Sheikh Hamdan bin Mohammed bin Rashid Al Maktoum, at the launch of the 'One Million AI Prompters' initiative in Dubai

KAYTUS Support for Intel ® Xeon ® 6 Processors - Unmatched AI Performance and Eco-Efficiency17.6.2024 09:02:00 CEST | Press release

KAYTUS, a leading IT infrastructure provider, announces that its servers now support the newly released Intel® Xeon® 6 Processors, which offer outstanding performance and energy efficiency, setting a new standard in the industry. Compared to servers equipped with 3rd Gen Intel® Xeon® Scalable Processors, the updated KAYTUS servers deliver a 200% performance boost and a 230% improvement in performance per watt, rigorously verified in virtualization scenarios and tasks such as decompression, video transcoding, and pgbench. The significant enhancement in performance per watt provides greener and more powerful computing support for diverse applications, including AI, cloud-native environments, and data analytics. KAYTUS continues to ensure that its clients benefit from the latest advancements in technology, achieving exceptional efficiency and performance. With the continuous development of artificial intelligence, particularly the rapid expansion and widespread application of AI technolog

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
HiddenA line styled icon from Orion Icon Library.Eye