Business Wire

PA-RQM+

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

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

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com
DK

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

Blue Shift Report Highlights Systemic Vulnerabilities Caused by the Hidden Cost of AI14.1.2026 10:00:00 CET | Press release

Arthur D. Little’s Blue Shift institute has published its latest report, AI’s Hidden Dependencies. This in-depth report, involving more than 50 experts, explores AI’s resource dependencies and the consequent direct systemic vulnerabilities for businesses and lays out strategic actions in response. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260114966898/en/ Arthur D. Little’s Blue Shift Institute has published its latest report, AI’s Hidden Dependencies With AI’s adoption and usage expected to remain on its growth trajectory, so is its strain on resources. The report notably identifies three main areas of dependency: Environmental impacts, including emissions due to AI’s heavy energy usage and the manufacture of related hardware Energy supply, including increased electricity demand and strain on the grid Compute infrastructure, including supply chain choke points and dependencies on dominant providers As AI is now becomin

Klarna Expands Digital Bank Offer with Peer-to-Peer Payments14.1.2026 09:00:00 CET | Press release

Klarna, the global digital bank and flexible payments provider, has launched instant peer-to-peer payments in 13 European countries, marking the next step in its evolution as a digital bank. The new feature enables Klarna customers to send money to friends and family, whether splitting bills or gifting cash, directly from the Klarna app: as simple as handing someone cash, with the protection of a regulated bank. This launch takes Klarna deeper into everyday banking, turning Klarna into a central hub for day-to-day spending and money management. It comes on the back of the Klarna Balance accounts and the rapid adoption of Klarna Card, with over 4 million sign-ups just four months after launch. Sebastian Siemiatkowski, co-founder and CEO of Klarna commented: “Customers are sick of the friction and fees of traditional banking, which is why millions signed up to Klarna Card within a few months of launch. With peer-to-peer payments we’re making it even easier to manage all of your payments

Northern Trust Secures Expanded Mandate with Swedish Pension Provider AMF Tjänstepension AB14.1.2026 09:00:00 CET | Press release

Providing Global Custody and Investment Operations Northern Trust (Nasdaq: NTRS) today announced that it has retained and expanded its mandate with AMF Tjänstepension AB (AMF), a leading Swedish pension provider. Under the renewed agreement, Northern Trust, which has serviced AMF for more than 20 years, will continue to serve as custodian for AMF’s global pension assets and add investment operations for trade services across AMF’s total portfolio, for both pension and fund company assets. AMF is one of Sweden’s leading pension companies, managing occupational pensions for millions of individuals. With a strong focus on delivering secure and sustainable retirement outcomes, AMF combines cost efficiency with long-term investment strategies to benefit its members. Petra Sjögerås, head of Nordic Region, Northern Trust said: “As a long-standing partner to institutions in the Nordic region, Northern Trust brings extensive experience and a solutions-oriented mindset to proactively support our

Notice Concerning Change of Representative Executive Officer14.1.2026 08:14:00 CET | Press release

H.U. Group Holdings, Inc. (the Company) today announced that it has resolved, at a meeting of the Board of Directors held on January 14, 2026, to change the Company’s Representative Executive Officer as described below. 1. Name and job titles of newly appointed Representative Executive Officer Name New title Current title Goki Ishikawa Representative Executive Officer, President and Group CEO Managing Executive Officer 2. Name and job titles of retiring Representative Executive Officer Name New title Current title Shigekazu Takeuchi Director and Executive Officer Director, Representative Executive Officer, Chairman, President and Group CEO 3. Reason for change In May 2025, toward realizing its Vision for 2035, the Company announced its Medium-Term Management Plan “H.U. 2030” (MMP) as well as its CEO succession plan including the timing for the selection of the next CEO. As the succession plan progressed, the Company has recognized that Mr. Goki Ishikawa is the best to lead the executio

TOXINS 2026: Clinical Updates on Galderma’s Leading Neuromodulator Portfolio Further Reinforce Its Leadership in Injectable Aesthetics14.1.2026 07:00:00 CET | Press release

Galderma will present data on Relfydess® (RelabotulinumtoxinA) – the first and only ready-to-use liquid neuromodulator designed with PEARL™ Technology – which further demonstrate its rapid onset and efficacy through 6 months in both moderate-to-severe frown lines (glabellar lines) and crow’s feet (lateral canthal lines)1-3 Dysport® (AbobotulinumtoxinA) data demonstrating high levels of patient and practitioner satisfaction after treatment of frown lines will also be presented4,5 Galderma will also present a Masterclass on the science behind Relfydess, demonstrating how the company is shaping the future of neuromodulation Galderma (SIX: GALD) will present data on its innovative and industry-leading neuromodulator portfolio at the TOXINS 2026 International Conference in Madrid, Spain from January 14-17, 2026. The company will share data from five abstracts on two neuromodulators from its portfolio, Relfydess – the first and only ready-to-use liquid neuromodulator designed with PEARL Tech

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
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye