PA-RQM+
20.5.2024 15:01:28 CEST | Business Wire | Press release
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
Eurofins Biomnis Launches New Clinical LC‑MS/MS Method for the Detection of Cereulide Toxin in Stool Samples11.3.2026 09:00:00 CET | Press release
Eurofins Biomnis, a leading European provider of specialised clinical diagnostics services, and part of the global network of Eurofins laboratories, announces the successful development and validation of a new liquid chromatography tandem mass spectrometry (LC‑MS/MS) method for the detection and quantification of cereulide toxin in human stool samples. This innovation underlines Eurofins Biomnis’ diagnostic innovation, and its commitment to contributing its expertise to reducing diagnostic uncertainty with solutions that support clinicians and laboratories nationwide and internationally. Eurofins Biomnis has fully validated the method for human stool samples, taking into account matrix effects and meeting the requirements of ISO 15189 (with the exception of inter‑method comparison on pathological clinical samples). Cereulide, a toxin produced by specific strains of Bacillus cereus, has recently raised significant public attention following contamination events involving infant formula
1NCE and Netmore Combine Cellular and LoRaWAN Access to Deliver Global IoT Coverage11.3.2026 08:40:00 CET | Press release
The two largest global providers of massive IoT networks partner to provide a combined offering of LoRaWAN® and Cellular connectivity. 1NCE now integrates Netmore’s LoRaWAN into the 1NCE OS platform, allowing customers to use both services seamlessly through its software stack. The new network addresses 90% of the LPWAN market and offers an unparalleled ability to eliminate coverage blind spots around the globe. 1NCE, a company offering a plug-and-play platform for creating and managing the world’s best IoT products, today opened access for its customers to the LoRaWAN® services of Netmore, the world’s leading low power wide area network operator for massive IoT. With growing demand for low power long range connectivity, the Netmore LoRaWAN Network Server (LNS) Plugin provides 1NCE customers access to cellular and LoRaWAN IoT coverage options through one platform. The launch of the Netmore Plugin marks the beginning of strategic collaboration to expand the combined offering of the two
1NCE and Netmore Combine Cellular and LoRaWAN Access to Deliver Global IoT Coverage11.3.2026 08:40:00 CET | Press release
The two largest global providers of massive IoT networks partner to provide a combined offering of LoRaWAN® and Cellular connectivity. 1NCE now integrates Netmore’s LoRaWAN into the 1NCE OS platform, allowing customers to use both services seamlessly through its software stack. The new network addresses 90% of the LPWAN market and offers an unparalleled ability to eliminate coverage blind spots around the globe 1NCE, a company offering a plug-and-play platform for creating and managing the world’s best IoT products, today opened access for its customers to the LoRaWAN® services of Netmore, the world’s leading low power wide area network operator for massive IoT. With growing demand for low power long range connectivity, the Netmore LoRaWAN Network Server (LNS) Plugin provides 1NCE customers access to cellular and LoRaWAN IoT coverage options through one platform. The launch of the Netmore Plugin marks the beginning of strategic collaboration to expand the combined offering of the two b
Codethink Opens Early Access to IEC 61508 Mapping for the Eclipse Trustable Software Framework11.3.2026 08:07:00 CET | Press release
Preview release invites industry collaboration on open source approach to functional safety assessment EMBEDDED WORLD--Codethink today opened early access to its mapping between the Eclipse Trustable Software Framework (TSF) and IEC 61508, the international standard governing the functional safety of electrical and electronic systems. The mapping establishes a transparent relationship between the engineering principles of the Trustable Software Framework and the objectives defined in IEC 61508. By making this work available as an early preview, Codethink is inviting organisations interested in applying open source approaches to functional safety to review and begin working with the mapping while the work continues to mature. IEC 61508 forms the foundation of many domain-specific safety standards, including ISO 26262 for automotive systems. The early access reflects Codethink’s long-standing commitment to open development of software engineering methods. “This preview release reflects o
Galderma Buys Back Shares Worth CHF 232 Million in the Context of Accelerated Bookbuild Offering11.3.2026 07:00:00 CET | Press release
Ad hoc announcement pursuant to Art. 53 LR Galderma (SIX: GALD), the pure-play dermatology category leader, today announced that it has agreed to repurchase 1.6 million shares at a price of CHF 143.75 per share for a total consideration of CHF 232 million in the context of the accelerated bookbuild offering (“ABO”) of Galderma shares by Sunshine SwissCo GmbH (“EQT”), Abu Dhabi Investment Authority (Private Equities Department) and Auba Investment Pte. Ltd. (all together the “Selling Shareholders”) launched yesterday evening. The repurchase was made at the same price per share determined by the bookbuilding offering. As a result of yesterday evening’s ABO, the Selling Shareholders have fully divested their remaining stake in Galderma. The repurchase, which is expected to settle on March 13 is being financed by Galderma’s existing liquidity on hand and will not affect the company’s ability to deliver on its strategic and financing priorities. The shares will be held in treasury for futur
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