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Rimsys Launches Community-Driven Regulatory Intelligence

Retrieved on:

Lunedì, Maggio 6, 2024

Medical Devices, Health, Technology, Health Technology, Software, RAPS, RAC, 2005 in television, Legislation, UDI

Rimsys, a leading regulatory information management software for the medtech industry, announced today the beta launch of its community-driven, centralized hub for global regulatory intelligence data, Rimsys Intel.

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Rimsys, a leading regulatory information management software for the medtech industry, announced today the beta launch of its community-driven, centralized hub for global regulatory intelligence data, Rimsys Intel.
Rimsys Intel builds upon Rimsys’ mission of increasing the availability of life-changing medical technologies by giving users free access to regulatory intelligence, including regulatory affiliations, legislation, UDI requirements, risk class information for medical devices and IVDs, in addition to market access requirements for each regulated country.
“As part of our core company value to empower each other, Rimsys believes that regulatory intelligence should be easily accessible and free.
To help keep Rimsys Intel up to date amid evolving global regulations, Rimsys is engaging RAPS Regulatory Affairs Certificate (RAC) holders.

Twist Bioscience Unveils Differentiated Ultra High-Throughput Library Preparation Solution at AGBT

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Lunedì, Febbraio 5, 2024

Built upon enzymatic fragmentation library preparation, the Twist Flex Prep UHT Kit utilizes novel chemistry that accepts and self-normalizes a wide range of sample input amounts through a new proprietary Normalization By Ligation (NBL) technology.

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Built upon enzymatic fragmentation library preparation, the Twist Flex Prep UHT Kit utilizes novel chemistry that accepts and self-normalizes a wide range of sample input amounts through a new proprietary Normalization By Ligation (NBL) technology.
The enhanced multiplexing further limits hands on time and saves researchers costs of reagents in downstream purification and indexing steps.
Twist will highlight its NGS tools in posters and presentations at the AGBT General Meeting taking place in Orlando, FL February 5-8, 2024.
Details are as follows:
Poster: Twist Pan-Cancer Reference Standards V2: Enhanced Precision and Reduced Errors in ctDNA Analysis

MCRA Announces European Expansion

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Mercoledì, Gennaio 10, 2024

Service, Patient, Notified body, Quality assurance, GDPR, Knowledge, Risk, MCRA, Medtech, Regulatory affairs, UDI, Contract research organization, Pharmaceutical industry

WASHINGTON, Jan. 10, 2024 /PRNewswire/ -- MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm is pleased to announce its expansion in Europe with three new offices in London, United Kingdom, Winterthur, Switzerland, and Eschborn, Germany.

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New Services and Offices in United Kingdom, Switzerland, and Germany
In addition to these new offices, MCRA has also expanded its service offerings in Europe to accommodate growing client needs.
MCRA Europe now offers GDPR compliance, representative services for clinical studies and Unique Device Identifier (UDI) services in addition to its core services of Regulatory Affairs, Clinical Research and Quality Assurance.
Abigail Allen, Vice President, Clinical Affairs states, "Our European presence further supports our global CRO by facilitating access to European patients and utilizing our country specific knowledge and expertise to streamline approvals and trial management.
Anthony Viscogliosi, CEO of MCRA, states "Europe is the second largest medical device market in the world.

Twist Bioscience Launches Full Length Unique Dual Index Adapters to Enable PCR-free Whole Genome Sequencing

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Martedì, Ottobre 31, 2023

Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, today announced the launch of Twist Full Length Unique Dual Index Adapters to enable PCR-free whole genome sequencing (WGS) and multiplexing at scale.

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Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, today announced the launch of Twist Full Length Unique Dual Index Adapters to enable PCR-free whole genome sequencing (WGS) and multiplexing at scale.
“With Twist Full Length UDI Adapters, we can enable PCR-free whole genome sequencing for our customers pursuing that approach, including our customers in Europe where PCR-free WGS has gained traction.”
Twist Full Length UDI Adapters add to Twist’s portfolio of universal adapter systems, which include Twist Universal Adapter System and Twist High Throughput Universal Adapter System.
Twist Full Length UDI Adapters include 1,536 indexes and come in automation-friendly configurations of 96 or 384 sets of adapters, giving customers the ability to multiplex anywhere between two and 1,536 samples.
The full length UDI adapters can be used in various NGS workflows and for PCR-free whole genome sequencing.

Surgical Instrument Tracking System Market to grow by USD 157.17 million from 2022 to 2027, North America to account for 41% of market growth- Technavio

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Mercoledì, Settembre 20, 2023

NEW YORK, Sept. 19, 2023 /PRNewswire/ -- The surgical instrument tracking system market is expected to grow by USD 157.17 million from 2022 to 2027.

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NEW YORK, Sept. 19, 2023 /PRNewswire/ -- The surgical instrument tracking system market is expected to grow by USD 157.17 million from 2022 to 2027.
In addition, the momentum of the market will progress at a CAGR of 9.34% during the forecast period, according to Technavio Research.
Surgical Instrument Tracking System Market: Segmentation Analysis
The market share growth by the hardware segment will be significant during the forecast period.
In addition, the mandatory adoption of Unique Device Identification (UDI) regulations in surgical instrument tracking is mainly expected to drive the growth of the hardware segment in the surgical instrument tracking system market.

Medical Components Inc. and Truveta partner to advance care for patients living with cancer and chronic kidney disease

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Martedì, Settembre 12, 2023

Belgian Medical Component, Cancer, UDI, Health, MPH, Patient, Research, EHR, Kidney disease, Medical device, MD

BELLEVUE, Wash., Sept. 12, 2023 (GLOBE NEWSWIRE) -- Medical Components, Inc. is partnering with Truveta to advance the use of real-world data to improve clinical care for patients battling cancer and kidney disease who require advanced vascular access for treatment.

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BELLEVUE, Wash., Sept. 12, 2023 (GLOBE NEWSWIRE) -- Medical Components, Inc. is partnering with Truveta to advance the use of real-world data to improve clinical care for patients battling cancer and kidney disease who require advanced vascular access for treatment.
Truveta delivers the most complete, timely, and clean electronic health record (EHR) data from more than 30 health systems, empowering researchers with scientifically rigorous, fast, and compliant analytics to study safety and effectiveness, improve patient care, and train medical AI.
Using the precise vascular device details – including universal device identification numbers (UDI) – within Truveta Data, Medical Components will be able to study the real-world use of their devices, identifying innovative optimizations and opportunities for improvement in patient care.
“We are honored to partner with an innovative medical device organization like Medical Components, working toward a shared mission of saving lives with data,” said Truveta Chief Medical Officer and Co-founder Ryan Ahern, MD, MPH.

Rising Demand for Operational Efficiency and Mobile Solutions Propels Growth of Global Digital Pharmaceutical Supply Chain Management Market, Projected to Expand at a CAGR of 8.2% by 2030 - ResearchAndMarkets.com

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Venerdì, Luglio 14, 2023

The "Global Digital Pharmaceutical Supply Chain Management Market, 2023-2030" report has been added to ResearchAndMarkets.com's offering.

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The "Global Digital Pharmaceutical Supply Chain Management Market, 2023-2030" report has been added to ResearchAndMarkets.com's offering.
The global digital pharmaceutical supply chain management market size is expected to reach USD 1.
84 billion by 2030, expanding at 8.2% CAGR from 2023 to 2030, according to this report.
These include the expanding usage of the GS1 Standard System and Unique Device Identification (UDI), the emergence of cloud-based solutions, the rising demand for operational cost reduction, and the increased use of mobile-based healthcare supply chain management solutions.

LEXISNEXIS® REED TECH TEAMS UP WITH REGDESK, A LEADING REGULATORY INFORMATION MANAGEMENT PLATFORM

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Giovedì, Maggio 25, 2023

Data management, EU, UDI, Unique, Intelligence, Reed Tech, Unique Device Identification, RIMS, AI, FDA, Medtech, Medical device, Cryptocurrency, HORSHAM

HORSHAM, Pa., May 25, 2023 /PRNewswire/ -- LexisNexis Legal & Professional today announced, that LexisNexis Reed Tech, provider of data management & analytic solutions for the life sciences industry, has expanded its collaboration with RegDesk, a provider of best-in-class Regulatory Information Management Systems Platform (RIMS). RegDesk offers a global submission management and regulatory intelligence platform powered by AI to provide an expedited way to prepare submissions and obtain insights into regulatory changes in over 120 countries. Current and prospective customers of both companies can effectively manage the increasing complexity of complying with ever-changing global regulations.

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HORSHAM, Pa., May 25, 2023 /PRNewswire/ -- LexisNexis Legal & Professional today announced, that LexisNexis Reed Tech, provider of data management & analytic solutions for the life sciences industry, has expanded its collaboration with RegDesk, a provider of best-in-class Regulatory Information Management Systems Platform (RIMS).
RegDesk offers a global submission management and regulatory intelligence platform powered by AI to provide an expedited way to prepare submissions and obtain insights into regulatory changes in over 120 countries.
LexisNexis® Reed Tech teams up with RegDesk, a leading Regulatory Information Management Platform
" RegDesk provides RIMS software that streamlines medical device registration and intelligence tracking for health authorities around the globe.
LexisNexis Reed Tech is expanding its collective of regulatory experts delivering solutions and services who support medical device and pharmaceutical manufacturers, distributors, and related operations.

SCENTAIR® PARTNERS WITH UNION DIVERSIFIED INDUSTRIES TO PROVIDE MEANINGFUL JOBS FOR UNDEREMPLOYED ADULTS WITH DEVELOPMENTAL DISABILITIES

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Giovedì, Maggio 4, 2023

Exercise, Volunteering, Organization, UDI, Partnership, Senior, Marketing, Whispering, Disability studies, Management

CHARLOTTE, N.C., May 4, 2023 /PRNewswire/ -- Global scent marketing leader ScentAir has partnered with local non-profit Union Diversified Industries (UDI) to provide jobs for individuals with developmental disabilities.

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CHARLOTTE, N.C., May 4, 2023 /PRNewswire/ -- Global scent marketing leader ScentAir has partnered with local non-profit Union Diversified Industries (UDI) to provide jobs for individuals with developmental disabilities.
ScentAir provides jobs for individuals with developmental disabilities across Charlotte, NC in partnership with UDI.
UDI partners with companies that have a global reach to bridge the gap between two major categories: underemployed adults with intellectual and developmental disabilities and manufacturing organizations that are looking to outsource repetitive processes.
"Our individuals are proud to produce items that are used in a variety of settings and applications," said CEO David Casper.

Global Healthcare Supply Chain Management Market to Reach $5.2 Billion by 2030: Growing Adoption of Mobile Based Healthcare Supply Chain Management Solutions Drive Growth - ResearchAndMarkets.com

Retrieved on:

Martedì, Aprile 11, 2023

Medical Supplies, Health, Cloud, Maintenance, GS1, Software as a service, JDA, RFID, COVID-19, UDI, Software, USD, Blue Yonder, Hospital, Panasonic, Vaccine, Warehouse

The global healthcare supply chain management market size is expected to reach USD 5.2 billion by 2030 and is expected to expand at a CAGR of 9.2% from 2022 to 2030.

Key Points:

The global healthcare supply chain management market size is expected to reach USD 5.2 billion by 2030 and is expected to expand at a CAGR of 9.2% from 2022 to 2030.
Cloud-based warehouse management systems assist supply chain performance by improving order management and production planning across all warehouse locations.
Other factors such as the adoption of GS1 standards and UDI and mobile-based healthcare management solutions also boost the market growth.
Major organizations are shifting toward digitalized supply chain managing solutions for rebuilding their supply chains and creating transparency and resiliency across their supply chain processes.