MDSAP

Rehabtronics Receives Certification for Medical Device Single Audit Program (MDSAP), Expediting Global Commercialization of its Upper Limb Rehabilitation Devices

Retrieved on: 
Mercredi, janvier 3, 2024
Rehabilitation, Medical device, Disease, MDSAP, Certification, Health Canada, Patient, Movement

VANCOUVER, BC, Jan. 3, 2024 /PRNewswire/ -- Rehabtronics Inc announces it has successfully upgraded its ISO13485:2016 quality certification to include the internationally-recognized Medical Device Single Audit Program (MDSAP) standard. The additional certification confirms the company's medical device manufacturing program achieves the regulatory audit requirements and compliance standards of Australia, Canada, and the United States.

Key Points: 
  • This Quality Assurance Certification confirms Rehabtronics has achieved regulatory audit and compliance requirements in numerous countries including the United States and Canada.
  • VANCOUVER, BC, Jan. 3, 2024 /PRNewswire/ -- Rehabtronics Inc announces it has successfully upgraded its ISO13485:2016 quality certification to include the internationally-recognized Medical Device Single Audit Program (MDSAP) standard.
  • The additional certification confirms the company's medical device manufacturing program achieves the regulatory audit requirements and compliance standards of Australia, Canada, and the United States.
  • "Obtaining this certification will allow us to bring our Class II products to Canadians," says Rehabtronics CEO Rahul Samant.

NeuroStar TMS Receives Expanded Regulatory Approval in Japan

Retrieved on: 
Lundi, décembre 4, 2023
Neuronetics, Marketing, Quality of life, Partnership, Depression, Medication, TMS, MDSAP, DSM-IV codes, Health, MDD, Patient, Transcranial magnetic stimulation, STIM, Dash, PMDA

The features covered in this approval include the NeuroStar 3.7 platform, MT Cap , D-Tect ™ MT Accessory, and the Dash treatment protocol.

Key Points: 
  • The features covered in this approval include the NeuroStar 3.7 platform, MT Cap , D-Tect ™ MT Accessory, and the Dash treatment protocol.
  • The Dash treatment protocol reduces the daily TMS treatment time from 38 minutes to under 19 minutes.
  • NeuroStar TMS Therapy aims to fill this unmet need through its exclusive distribution partnership with Teijin Pharma Limited.
  • NeuroStar is advancing its global strategy and strengthening its global presence with recent announcements of regulatory approval in South Korea , as well as EU-MDR and MDSAP certifications.

bioLytical Laboratories Inc. Donates Tests to Help Boost International Testing Access Ahead of International Testing Week

Retrieved on: 
Mercredi, novembre 22, 2023
Partnership, HIV/AIDS, Infection, NGO, Health, MDSAP, Coalition, Hepatitis, STI, Public, HIV, Patient, Viral hepatitis, Vaccine

International Testing Week, scheduled for November 22- 28 this year, helps raise awareness of the importance of accessible testing for individual and public health.

Key Points: 
  • International Testing Week, scheduled for November 22- 28 this year, helps raise awareness of the importance of accessible testing for individual and public health.
  • Robert Mackie, CEO, bioLytical, emphasizes the significance of International Testing Week and states, "International Testing Week serves as a global reminder of the critical role rapid testing plays in safeguarding public health.
  • By donating these tests, bioLytical and Coalition PLUS aim to address the disparities in healthcare access and testing capabilities worldwide.
  • In 2022, bioLytical launched iStatis, its new lateral flow testing platform, to create additional access to testing worldwide.

AIRS Medical Accelerates Global Expansion, Showcasing clinical achievements of MRI Enhancement Solution at RSNA 2023

Retrieved on: 
Lundi, octobre 30, 2023
Air medical services, Pharmaceuticals and Medical Devices Agency, RSNA, MRI, US, Clinical research, ISO/IEC, US FDA, Medicine, Certification, Research, Medicines and Healthcare products Regulatory Agency, Radiology, PMDA, Growth, Theatre, Abstract, ISO, MDSAP, Medical device, Medical imaging

Attending at RSNA 2023 as an AI showcase sponsor, showcasing clinical achievements with two AI Theater Presentations and two accepted abstracts.

Key Points: 
  • Attending at RSNA 2023 as an AI showcase sponsor, showcasing clinical achievements with two AI Theater Presentations and two accepted abstracts.
  • SEOUL, South Korea, Oct. 30, 2023 /PRNewswire/ -- AIRS Medical has shown remarkable growth in global market expansion.
  • AIRS Medical will showcase SwiftMR™, an AI-powered MRI enhancement solution at RSNA2023, the largest radiological conference in North America on November 24~29th.
  • AIRS Medical accelerates international expansion with the recent certification of Japan's Pharmaceuticals and Medical Devices Agency (PMDA) on October 13th.

Femasys Inc. MDSAP Surveillance Audit Successfully Completed

Retrieved on: 
Mardi, octobre 3, 2023
ISO, Accounting and Auditing Organization for Islamic Financial Institutions, Woman, Infertility, MDSAP, Food and Drug Administration, Certification, Medical device, TUV, FDA, Lewis Galoob Toys, Inc. v. Nintendo of America, Inc.

ATLANTA, Oct. 03, 2023 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a lead late-clinical stage product candidate and innovative diagnostic products, today announced that it has successfully completed the annual Medical Device Single Audit Program (MDSAP) surveillance audit with no nonconformances and no findings.

Key Points: 
  • – Femasys demonstrates compliance with harmonized regulatory requirements for Australia, Brazil, Japan, Canada and the USA –
    ATLANTA, Oct. 03, 2023 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a lead late-clinical stage product candidate and innovative diagnostic products, today announced that it has successfully completed the annual Medical Device Single Audit Program (MDSAP) surveillance audit with no nonconformances and no findings.
  • Femasys currently holds Certificates of Registration for MDSAP from TUV SUD America Inc., a recognized Auditing Organization and Notified Body that conducts a single regulatory audit of medical device manufacturers that satisfies the relevant harmonized regulatory requirements for the countries participating in the MDSAP program, and ISO 13485 Quality System Certification for the commercialization of Femasys products in the U.S., Canada and Japan with the ability to register for market authorization in Australia and Brazil.
  • “Completion of the MDSAP annual surveillance audit with no nonconformances and no findings demonstrates the robustness of the Femasys Quality System and our continued commitment to compliance that extends to all of our in-house manufacturing capabilities,” said Kathy Lee-Sepsick, founder, president and chief executive officer of Femasys.
  • “We look forward to continuing to advance our much-needed innovative technologies in the U.S., as well as other countries around the world, via the MDSAP program."

AIRS Medical Inc. receives MDSAP Certification, Paving the Way for Global Expansion

Retrieved on: 
Mercredi, septembre 13, 2023
Acceleration, Certification, Medicine, MRI, Medical device, Air medical services, Patient, MDSAP

The MDSAP certification stands as a testament to AIRS Medical's adherence to top-tier quality management practices.

Key Points: 
  • The MDSAP certification stands as a testament to AIRS Medical's adherence to top-tier quality management practices.
  • This endorsement signifies that AIRS Medical's quality management system has met the exacting standards set forth by the MDSAP regulatory framework.
  • By streamlining the regulatory processes across multiple jurisdictions, AIRS Medical Inc. can now navigate the complex landscape of global markets with heightened efficiency.
  • "At AIRS Medical, we've always been driven by a commitment to excellence and innovation," says Hyeseong Lee, CEO of AIRS Medical.

Aequus Reports Second Quarter 2023 Financial Highlights and General Update

Retrieved on: 
Mercredi, août 30, 2023
Marketing, Eye, OTCQB, G&A, AQS, MDSAP, Patient, Q4, Health Canada, YTD, PF, Pharmaceutical industry, Novartis, Second

Net losses decreased by 9.22 % in Second Quarter 2023 compared to the same period last year, with the Second Quarter 2023 net loss of $700,875 versus a $772,100 loss in the three months ended June 30, 2022 (“Second Quarter 2022”).

Key Points: 
  • Net losses decreased by 9.22 % in Second Quarter 2023 compared to the same period last year, with the Second Quarter 2023 net loss of $700,875 versus a $772,100 loss in the three months ended June 30, 2022 (“Second Quarter 2022”).
  • Highlights from the quarter are as follows:
    Sales and marketing costs for Second Quarter 2023 were $372,844 compared to $663,082 in Second Quarter 2022, a decrease of $290,238 or 44%.
  • The Company incurred research and development (“R&D”) expenses of $25,824 in Second Quarter 2023 compared to $7,945 in Second Quarter 2022.
  • General and administration (“G&A”) expenses were $353,584 in Second Quarter 2023 compared to $457,177 in Second Quarter 2022, a decrease of $103,593.

Aequus Pharmaceutical Canada Announces a Pause in Sales of Evolve Intensive Eyedrops and Gel in Canada

Retrieved on: 
Vendredi, août 18, 2023
Certification, Notified body, Intensive word form, OTCQB, Patient, AQS, MDSAP, Medical device

VANCOUVER, British Columbia, Aug. 18, 2023 (GLOBE NEWSWIRE) -- Aequus Pharmaceuticals Inc. (TSX-V: AQS , OTCQB: AQSZF ), ) (“Aequus” or the “Company”), a specialty pharmaceutical company announces the pause of sales of its Evolve Intensive eyedrop and Intensive gel products in Canada.

Key Points: 
  • VANCOUVER, British Columbia, Aug. 18, 2023 (GLOBE NEWSWIRE) -- Aequus Pharmaceuticals Inc. (TSX-V: AQS , OTCQB: AQSZF ), ) (“Aequus” or the “Company”), a specialty pharmaceutical company announces the pause of sales of its Evolve Intensive eyedrop and Intensive gel products in Canada.
  • Until this process is completed, Aequus Pharmaceuticals will pause sales of the class leading Evolve® range of products in the Canadian market.
  • We look forward to Evolve® returning to patients in Canada as soon as MDSAP Certification is issued.
  • Aequus and Medicom Healthcare assure valued customers and eyecare professionals that the Evolve® Intensive eyedrops and gel will return to the Canadian market soon.

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: 
Mardi, août 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.

MedReg 2023: Annual Medical Device Regulatory Confex - Navigating Regulatory Horizons

Retrieved on: 
Mardi, août 15, 2023
DMR, CAPA, USS Medregal (SS-480), Federal Food, Drug, and Cosmetic Act, PM, ISO, Calendar, DHR, MDSAP, NextGen Healthcare, Organization, MDR, PMA, Design controls, VPS, Knowledge, DHF, AM, FDA, US FDA, Element, Medical device, Powder metallurgy, EU

DUBLIN, Aug. 15, 2023 /PRNewswire/ -- The "MedReg 2023 - Annual Medical Device Regulatory Confex" training has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, Aug. 15, 2023 /PRNewswire/ -- The "MedReg 2023 - Annual Medical Device Regulatory Confex" training has been added to ResearchAndMarkets.com's offering.
  • Step into the realm of regulatory excellence at MedReg 2023, the Annual Medical Devices Regulatory Confex that promises to revolutionize attendees' understanding of medical device regulations.
  • A compelling picture is painted by envisioning a world where medical device regulations are overlooked - a world that compromises patient safety.
  • MedReg 2023 transcends traditional learning, offering an experience designed to excite, inspire, and invigorate attendees' regulatory spirit.