Medical device design

ExThera Medical Receives Certification for Medical Device Single Audit Program (MDSAP) and Recertification for International Organization for Standardization for Medical Devices (ISO 13485)

Retrieved on: 
Tuesday, August 15, 2023
Medical Devices, Infectious Diseases, Hospitals, Health, Oncology, Seraph, EUA, Medical device, Investigational device exemption, ANVISA, MHLW, ISO, COVID-19, NAE, MDSAP, Quality, Certification, MDD, Patient, Blood, European, HC, IDE, International Organization (journal), FDA, TGA, International Organization for Standardization, Medical device design, Pharmaceutical industry

ExThera Medical Corporation announces it has received simultaneous certification per Medical Device Single Audit Program (MDSAP) and International Organization for Standardization (ISO 13485) requirements.

Key Points: 
  • ExThera Medical Corporation announces it has received simultaneous certification per Medical Device Single Audit Program (MDSAP) and International Organization for Standardization (ISO 13485) requirements.
  • MDSAP certification confirms comprehensive achievement of regulatory audit requirements and compliance standards for medical device manufacturers looking to sell products within the United States (FDA), Canada (HC), Japan (MHLW), Australia (TGA), and Brazil (ANVISA).
  • MDSAP certification has the added benefit of potentially expediting the timetable to commercialization within these participating geographies.
  • The internationally recognized ISO 13485 certification further confirms achievement of medical device manufacturer quality standards requirements necessary for global market entry.

Eseye launches the industry's first IoT Readiness Level Index: A Ground-breaking Framework to Measure Readiness for IoT Adoption

Retrieved on: 
Thursday, May 25, 2023
Data management, Partnership, Failure, IRL, Internet of things, TRL, Weighted least squares, Certification, Technology readiness level, Device, NASA, Risk, City, Medical device design, Customer service, Risk management, Launch pad

"We recognised that every IoT use case is different, and many were struggling to successfully launch an IoT solution.

Key Points: 
  • "We recognised that every IoT use case is different, and many were struggling to successfully launch an IoT solution.
  • In addition to the IoT Readiness Framework, Eseye has also introduced a new subscription-based service offering called IoT LaunchPad™.
  • As IoT projects continue to become mainstream IRLs will become increasingly important in ensuring future success of IoT implementations.
  • To learn more about Eseye's IoT Readiness Level Index and to schedule an assessment for your organisation, visit the Eseye website .

MicroVention Announces Continued Achievements with its Door to the Future Program with the Republic of Costa Rica; President Rodrigo Chaves Robles Signs National Employment Program Decree at MicroVention Today and Tours Door to the Future Lab

Retrieved on: 
Tuesday, April 11, 2023
Research, General Health, Consumer, Medical Devices, Health Technology, Public Relations, Investor Relations, Science, Cardiology, Biotechnology, Women, Communications, Health, Other Science, Social responsibility, Partnership, Medical device design, Curriculum, Team building, Social, Woman, Cultural center, National Employment Standards, Metric, Government, Life skills, Republic, Terumo, Social Security, Environmental Health (journal), Tecnia Institute of Advanced Studies, Labour, Nursing, Tourism

President Rodrigo Chaves Robles also toured MicroVention’s innovative Door to the Future Lab, supporting the National Employment decree.

Key Points: 
  • President Rodrigo Chaves Robles also toured MicroVention’s innovative Door to the Future Lab, supporting the National Employment decree.
  • This is the result of the evaluations conducted in the program and improvements that have been integrated into this new decree.
  • MicroVention’s Door to the Future Program provides meaningful work and life training for individuals from underserved communities.
  • MicroVention offers three separate programs per year, with thirty-six people chosen for each group in the hopes of landing full-time, meaningful employment.

NEUMA, The Design And Testing Arm Of Kymanox, Moves To New Headquarters

Retrieved on: 
Thursday, January 5, 2023
CISS, Medical device, AAMI, Ciccarelli, Medical device design, Association for the Advancement of Medical Instrumentation, Certification, Quality management system, DV, Radiation, QMS, Development, Electrical engineering, Software, FDA, First Avenue, Specialization, Device file, Combination product, Engineering, Sterilization

The new NEUMA headquarters provides a significant upgrade in meeting space for customer engagement as well as expanded lab space for prototyping and testing.

Key Points: 
  • The new NEUMA headquarters provides a significant upgrade in meeting space for customer engagement as well as expanded lab space for prototyping and testing.
  • In particular, this new space enables the Kymanox Lab Services function to offer full-service Design Verification (DV) Testing activities, from early-stage test method development through method validation and DV execution.
  • In addition to design and testing services, NEUMA continues to expand its service offerings particularly in the field of sterilization engineering.
  • Verifying device requirements through formal performance testing is a major milestone for combination product and medical device programs.

ManpowerGroup Talent Solutions' Total Workforce Index™ Reveals United States, Singapore, and Canada as the Top Markets for Talent

Retrieved on: 
Thursday, November 17, 2022
Generation Z, Growth, Technology, Disability, Gaps, Solution, Acquisition, AMERICAS, TWI, Czech Republic, Legislation, Organization, Efficiency, Workforce, Medication, Industry, RPO, View, EMEA, Time, Medical device design, Ageing, Medical device, NYSE, World, Multimedia, Specialization, Female, Digital rights management, Ministry of Information Technology and Telecommunication, Overalls, APAC, Employment, Engineering, Pharmaceutical industry, Creative industries, Drug, Retail, Equality, ManpowerGroup, Woman, Index, Biotechnology, Telecommunication

Now in its ninth year, the Total Workforce Index analyzes more than 200 factors to evaluate workforce availability, cost efficiency, regulation, and productivity across 69 markets.

Key Points: 
  • Now in its ninth year, the Total Workforce Index analyzes more than 200 factors to evaluate workforce availability, cost efficiency, regulation, and productivity across 69 markets.
  • MILWAUKEE, Nov. 17, 2022 /PRNewswire/ --The ManpowerGroup (NYSE: MAN) Talent Solutions 2022 Total Workforce Index (TWI) reveals the U.S., Singapore, and Canada as the highest-rankinglabor markets across the globe for sourcing, hiring, and retaining talent.
  • These findings were combined with big data and expert analysis to assess the workforce engagement of 69 global markets.
  • The markets that rank highest in the Total Workforce Index are those with the highest relative performance across all four categories.

FDA Grants Breakthrough Device Designation for Dexcom Hospital CGM System

Retrieved on: 
Tuesday, March 1, 2022
FDA, Diabetes, Medical Devices, Hospitals, Health, Risk, Diagnosis, Patient, Â, Hospital, CGM, Paracetamol, FDA, G6, COVID-19, Hypoglycemia, Caregiver, Diabetes, DXCM, Medical device design, Device, NASDAQ, Medical device, Pharmaceutical industry, Dexcom

DexCom, Inc. (NASDAQ:DXCM), the global leader in real-time continuous glucose monitoring (CGM) for people with diabetes, announced today the FDA has granted Breakthrough Device Designation for Dexcom CGM use in the hospital setting.

Key Points: 
  • DexCom, Inc. (NASDAQ:DXCM), the global leader in real-time continuous glucose monitoring (CGM) for people with diabetes, announced today the FDA has granted Breakthrough Device Designation for Dexcom CGM use in the hospital setting.
  • Dexcom CGM uses a small, wearable sensor and transmitter to continuously measure and send glucose levels wirelessly to a smart device*, providing real-time glucose data without the need for fingersticks.
  • Breakthrough Device Designation from the FDA could be transformative for using CGM for in-patient care in hospitals.
  • During the COVID-19 pandemic, the FDA allowed Dexcom CGM to be used in hospitals to help health care providers manage patient glucose levels, said Gil Rivas, vice president, general manager of hospital at Dexcom.

Amy-Jo Yogmas is Appointed President of Boekel Scientific

Retrieved on: 
Wednesday, December 15, 2021
Boekel, Professional, ISO, History, Board, Life, OEM, Intelligence, SCOPE, Freedom, ISO 13485:2003, UV, Director, Plasma, Vice, Research, Marketing, Goal, Medical device design, Patient, Knowledge, Efficiency, Coronavirus, Incubator, CO2, Medical device

PHILADELPHIA, Dec. 15, 2021 /PRNewswire-PRWeb/ -- Boekel Scientific , a globally recognized designer and manufacturer of laboratory equipment and medical devices, has announced the promotion of Amy-Jo Yogmas to President, effective immediately.

Key Points: 
  • PHILADELPHIA, Dec. 15, 2021 /PRNewswire-PRWeb/ -- Boekel Scientific , a globally recognized designer and manufacturer of laboratory equipment and medical devices, has announced the promotion of Amy-Jo Yogmas to President, effective immediately.
  • Yogmas has 17 years of progressively responsible executive experience at Boekel Scientific in the areas of sales, marketing, quality, and operations.
  • Yogmas assumes leadership of Boekel Scientific with a mandate to fulfill the company vision of global leadership in the supply and innovation of life science tools.
  • It drives a continuing emphasis on innovation in product development and unmatched quality standards for all equipment and tools bearing the Boekel Scientific brand name.

Somne Launches with New Noninvasive Technology to Treat Sleep Apnea

Retrieved on: 
Wednesday, August 18, 2021
CPAP, Sleep, Sleep apnea, Type 2 diabetes, OSA, Degenerative disease, Ageing, Dementia, Variable, Neck, Patient, Obstructive sleep apnea, Medical device design, CEO, FDA, Intellectual Ventures, IRB, Pharmaceutical industry

BELLEVUE, Wash., Aug. 18, 2021 /PRNewswire/ -- Globally nearly one billion adults aged 30 to 69 years are estimated to have obstructive sleep apnea (OSA).1 Somne, a digital health company focused on solving sleep apnea comfortably, announced it is developing a revolutionary non-invasive alternative to CPAP.

Key Points: 
  • BELLEVUE, Wash., Aug. 18, 2021 /PRNewswire/ --Globally nearly one billion adults aged 30 to 69 years are estimated to have obstructive sleep apnea (OSA).1 Somne, a digital health company focused on solving sleep apnea comfortably, announced it is developing a revolutionary non-invasive alternative to CPAP.
  • Somne's device for sleep apnea treatment is worn around the neck and uses patented Variable Negative Pressure (vNEP) technology2 to provide therapy to patients while they sleep.
  • To learn more about Somne's sleep apnea device, visit Somne.co
    Somne is a digital health company that has created a new prototype device to comfortably treat obstructive sleep apnea (OSA).
  • The Somne neck collar prototype uses patented Variable Negative Pressure technology (vNEP) to provide a comfortable fit, better sleep, and improved health outcomes.

BRS LAUNCHES MASK MANUFACTURING OPERATIONS TO SUPPORT U.S. PPE DEMAND

Retrieved on: 
Friday, September 11, 2020
BRS, Medical device design, Food and Drug Administration, Premarket tobacco application, Health in the United States, Health

When BRS was created earlier this year, medical device manufacturing was part of our predetermined business strategy, said Russ Rogers, CEO of BRS.

Key Points: 
  • When BRS was created earlier this year, medical device manufacturing was part of our predetermined business strategy, said Russ Rogers, CEO of BRS.
  • In addition, BRS provides regulatory and scientific services, including U.S. FDA Premarket Tobacco Applications (PMTA) and CBD clean room manufacturing.
  • BRS has the bandwidth to exponentially expand current face mask production based on customer needs and demand.
  • We are very excited to partner with the team at BRS to support the demand challenges facing the healthcare supply chain, said Jay Stotlar, President at Hutchins & Hutchins, one of BRS first customers for its face mask production.

Strides Made in Additive Manufacturing Drive 3D Printing Medical Devices Market; Relentless Research by Top Players Makes North America Lucrative Region - TMR

Retrieved on: 
Friday, May 29, 2020
Emerging technologies, Industrial design, Industrial processes, Articles, 3D printing, DIY culture, Medical device design, Medical device, Technology, Economic sectors

Cost-efficiency and productivity gains for medical device manufacturers using 3D printing systems and materials will help the market reach new heights.

Key Points: 
  • Cost-efficiency and productivity gains for medical device manufacturers using 3D printing systems and materials will help the market reach new heights.
  • The current valuation of the 3D printing medical devices market stood at US$823.0 million in 2016 and is projected to expand at 17.7% CAGR from 2017 to 2025 (the forecast period).
  • Strategic investments by leading players will help unlock new prospects in the 3D printing medical devices market, note analysts at TMR.
  • Leading segments of the global 3D printing medical device market:
    3D Printing Medical Device Market, by Component