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
Samsung Biologics Strike: Labor Union Warns of CDMO Supply Chain Risks Following Overwhelming Vote30.3.2026 11:52:00 CEST | Press release
Union members overwhelmingly approve strike action with 95.52% voting in favor on a 95.38% turnout, clearing the final legal hurdle after mediation ceased.Union emphasizes this is a fight against structural corporate governance issues, citing unresolved allegations concerning unfair labor practices and ESG compliance risks.Management adhered to a group-level wage guideline rather than bargaining on the basis of Samsung Biologics' own performance, exposing a lack of independent bargaining authority. The Samsung Biologics Labor Union (President: Jaesung Park), representing approximately 75% of the company's total employees, announced today that its members have overwhelmingly voted in favor of a strike, with 95.52% voting in favor on a 95.38% turnout during a voting period from March 24 to March 29. Following the Incheon Regional Labor Relations Commission's decision to cease mediation, the union has now secured the legal mandate to strike. The union stressed that this strike is not mere
The Premier Jumping League (PJL) Launches with a Record-Breaking $300 Million Guaranteed Prize Pot, Defining a New Era for Showjumping30.3.2026 11:00:00 CEST | Press release
The PJL empowers riders to compete as full-time professional athletes while working towards a sustainable economic model for the sport. Backed by McCourt Global and shaped by a leadership team with decades of experience in equestrian competition, sport, and entertainment, the PJL sets a new, sustainable, and globally relevant standard for elite jumping. Sixteen teams will compete across fourteen iconic international venues throughout Europe, North America, and the Middle East when the inaugural season opens in March 2027. The Premier Jumping League (PJL) launches with a record-breaking $300 million guaranteed prize pot, defining a new era for showjumping. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260330990938/en/ Photography credits: Daniel Benson for The Premier Jumping League/ Wieden+Kennedy London Backed by McCourt Global and its Executive Chairman, Frank McCourt, the PJL is a groundbreaking global competition that e
Dompé Announces First Patient Enrolled in New Study of Intranasal NGF in Cerebral Palsy30.3.2026 11:00:00 CEST | Press release
Cerebral Palsy (CP) refers to a group of permanent disorders in the development of movement and posture, which causes activity limitations, and is attributed to non-progressive disturbances that occurred in the developing fetal or infant brain.1 Nerve growth factor (NGF) is a naturally-occurring protein that supports damaged nerve cells and improves nervous system signaling, Dompé is investigating whether intranasal NGF has the potential to improve movement and neurodevelopment and address underlying brain damage in people with CP. Dompé’s intranasal NGF platform builds on the Nobel Prize-winning discovery of neurobiologist Professor Rita Levi-Montalcini and biochemist Dr. Stanley Cohen. Dompé, a leading biopharmaceutical company with operations in Italy and in the U.S., announced that the first patient has been enrolled at the Agostino Gemelli IRCCS University Hospital in Rome, Italy, in a Phase 2 investigational study of an intranasal form of Nerve Growth Factor (NGF) (Cenegermin-bkb
IQM Secures €50M Financing to Accelerate Global Growth30.3.2026 08:00:00 CEST | Press release
€50 million financing package from funds and accounts managed by BlackRock will support IQM to scale operations, accelerate product development, and strengthen its market position. The facility will support acceleration of IQM’s technology roadmap, fuel R&D, support entry into additional markets, and advance IQM’s leadership in quantum computing as IQM prepares for public listing. IQM Finland Oy, a global leader in full-stack superconducting quantum computers (“IQM”, “IQM Quantum Computers” or the “Company”), today announced it has secured a €50 millionfinancing package from funds and accounts managed by BlackRock. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260329996942/en/ IQM Radiance quantum computer is located in IQM's showroom in Espoo, Finland. This facility will support acceleration of IQM’s technology roadmap, fuel R&D, support entry into additional markets, and advance IQM’s leadership in quantum computing. This
Bureau Veritas and Trade Technologies Join Forces to Streamline Global Trade Operations30.3.2026 07:45:00 CEST | Press release
Bureau Veritas, a global leader in Testing, Inspection, and Certification services (TIC), through its Swiss branch Government Services Division, is pleased to announce a strategic agreement with Trade Technologies, the leading provider of trade finance automation, connectivity and transaction management services. This collaboration is a significant step toward reducing the complexities of international trade operations, particularly in regions where regulatory and inspection controls remain stringent. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260329411683/en/ Addressing Critical Trade Finance Challenges The agreement comes at a pivotal time for global trade. Letters of Credit (LCs) continue to serve as essential instruments in international commerce, particularly across the Middle East and Africa, where counterparty risk, foreign exchange controls, sanctions exposure, and regulatory oversight face ongoing challenges. In
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