Medical Device Regulation Act

Intensive 1 Day Virtual Course on Introduction to Human Factors for Pharmaceutical and Medical Device Professionals: Ethics, Consent and User Safety Along with How ISO 14971:2019 is Used - ResearchAndMarkets.com

Retrieved on: 
Wednesday, November 22, 2023

The "An Introduction to Human Factors for Pharmaceutical and Medical Device Professionals" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "An Introduction to Human Factors for Pharmaceutical and Medical Device Professionals" conference has been added to ResearchAndMarkets.com's offering.
  • This intensive one-day course will introduce those who are new to medical device design and development to the critical elements of the human factors and usability engineering process.
  • A focus on ethics, consent and user safety shall be described, along with how ISO 14971:2019 is used alongside any human factors process.
  • Post-market surveillance human factors shall also be detailed since this area is becoming increasingly important to include.

Pixyl receives FDA clearance for AI-powered brain MRI software Pixyl.Neuro™

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Monday, November 20, 2023

GRENOBLE, France, Nov. 20, 2023 /PRNewswire/ -- Pixyl has announced FDA 510(k) clearance for Pixyl.Neuro™, the next-generation AI software for brain MRI analysis that recently demonstrated enhanced detection rates up to 28%1.

Key Points: 
  • GRENOBLE, France, Nov. 20, 2023 /PRNewswire/ -- Pixyl has announced FDA 510(k) clearance for Pixyl.Neuro™, the next-generation AI software for brain MRI analysis that recently demonstrated enhanced detection rates up to 28%1.
  • Pixyl is an award-winning French medtech specializing in AI-powered MRI solutions to improve patient care.
  • "AI-driven MRI analysis opens the possibility of accessing previously unavailable clinically-relevant information to reinforce radiology workflows, especially in the context of neurological disorders."
  • We chose Pixyl to answer our routine practice needs based on their track-record of delivering high-quality brain MRI solutions.

3D Systems’ Extrusion Technology to Produce Patient-specific PEEK Implants Supports Ground-breaking Cranial Surgeries at Leading European Hospitals

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Tuesday, October 17, 2023

3D Systems’ extrusion printing technology is unique as its architecture and design are easy to use to produce durable, biocompatible implants using Polyetheretherketone (PEEK) material.

Key Points: 
  • 3D Systems’ extrusion printing technology is unique as its architecture and design are easy to use to produce durable, biocompatible implants using Polyetheretherketone (PEEK) material.
  • Additionally, the technology enables the production of patient-specific geometries at the hospital itself providing tremendous benefits to both surgeons and patients.
  • The implant was then produced in the Hospital’s 3D printing lab using VESTAKEEP® i4 3DF PEEK by Evonik on 3D Systems’ EXT 220 MED extrusion platform.
  • The cranial implant was printed using VESTAKEEP® i4 3DF PEEK by Evonik on 3D Systems’ EXT 220 MED extrusion platform.

Moon Surgical Announces CE Mark for Its Commercial Maestro System

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Tuesday, September 19, 2023

Moon Surgical , a French-American pioneer in collaborative robotics, announced today that the latest version of its Maestro System is CE Marked under the Medical Device Regulation (EU) 2017/745.

Key Points: 
  • Moon Surgical , a French-American pioneer in collaborative robotics, announced today that the latest version of its Maestro System is CE Marked under the Medical Device Regulation (EU) 2017/745.
  • View the full release here: https://www.businesswire.com/news/home/20230919460931/en/
    The latest version of the Maestro Surgical Robotics System by Moon Surgical, now also carries the CE Mark.
  • The Maestro System is designed to provide an accessible and enhanced version of traditional laparoscopy to over 18 million patients undergoing soft tissue procedures annually who currently lack the benefits of robotic surgical platforms.
  • The initial version of the Maestro System obtained its CE Mark earlier this April.

OD-OS GmbH at ESCRS 2023: Recent MDR certification of Navilas® underlines its advanced standard in retina lasers and opens path to new developments

Retrieved on: 
Thursday, September 7, 2023

TELTOW, Germany, Sept. 7, 2023 /PRNewswire/ -- Just in time for the ESCRS conference taking place Sep 8-11, 2023 in Vienna, OD-OS GmbH is announcing that its Quality Management System and the Navilas® Laser System 577s have been certified in accordance with the Medical Devices Regulation (EU) 2017/745 (EU MDR). Navilas® is one of the first laser products for medical retina to achieve certification according to new MDR standards. The only navigated retina laser with integrated eye tracking technology is a step beyond traditional slit-lamp lasers. It is transforming posterior pole laser care thanks to enhanced precision, speed and digital integration paving the way to further standardization and automation. The 577nm yellow laser also includes a subthreshold microsecond pulsing and an anterior treatment mode.

Key Points: 
  • Navilas® is one of the first laser products for medical retina to achieve certification according to new MDR standards.
  • The only navigated retina laser with integrated eye tracking technology is a step beyond traditional slit-lamp lasers.
  • It is transforming posterior pole laser care thanks to enhanced precision, speed and digital integration paving the way to further standardization and automation.
  • Dr. Winfried Teiwes, Managing Director, OD-OS GmbH: "We are very proud to have passed this important quality review of our processes and products.

OD-OS GmbH at ESCRS 2023: Recent MDR certification of Navilas® underlines its advanced standard in retina lasers and opens path to new developments

Retrieved on: 
Thursday, September 7, 2023

TELTOW, Germany, Sept. 7, 2023 /PRNewswire/ -- Just in time for the ESCRS conference taking place Sep 8-11, 2023 in Vienna, OD-OS GmbH is announcing that its Quality Management System and the Navilas® Laser System 577s have been certified in accordance with the Medical Devices Regulation (EU) 2017/745 (EU MDR). Navilas® is one of the first laser products for medical retina to achieve certification according to new MDR standards. The only navigated retina laser with integrated eye tracking technology is a step beyond traditional slit-lamp lasers. It is transforming posterior pole laser care thanks to enhanced precision, speed and digital integration paving the way to further standardization and automation. The 577nm yellow laser also includes a subthreshold microsecond pulsing and an anterior treatment mode.

Key Points: 
  • Navilas® is one of the first laser products for medical retina to achieve certification according to new MDR standards.
  • The only navigated retina laser with integrated eye tracking technology is a step beyond traditional slit-lamp lasers.
  • It is transforming posterior pole laser care thanks to enhanced precision, speed and digital integration paving the way to further standardization and automation.
  • Dr. Winfried Teiwes, Managing Director, OD-OS GmbH: "We are very proud to have passed this important quality review of our processes and products.

Medimaps Group Receives EU Certification Under the Medical Device Regulation

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Monday, September 4, 2023

Medimaps Group, a Swiss/Global med-tech company specializing in image-processing software with AI capabilities for assessing bone health, announced today it received the Medical Device Regulation (MDR) certification from its notified body BSI (CE 2797) for its management system and product portfolio.

Key Points: 
  • Medimaps Group, a Swiss/Global med-tech company specializing in image-processing software with AI capabilities for assessing bone health, announced today it received the Medical Device Regulation (MDR) certification from its notified body BSI (CE 2797) for its management system and product portfolio.
  • By successfully navigating the rigorous requirements of the Medical Device Regulation, our company proves its ability to deliver innovative and reliable solutions that meet the highest regulatory standards for the benefit of patients, healthcare professionals and medical business partners”, said Prof. Didier Hans, co-founder and CEO of Medimaps Group.
  • The certification ensures that medical device manufacturers meet the most stringent quality requirements in order to commercialize their products in Europe.
  • With this certification, Medimaps Group can continue to supply without interruptions certified TBS iNsight™ software at the highest standard to its valued customers in Europe and subsequent markets.

VenusP-Valve granted IDE approval for clinical trial, unveiling a new chapter for Chinese valve solutions globally

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Monday, August 7, 2023

VenusP-Valve, thus, has become the first China-developed heart valvular system to be approved by the FDA for clinical trial, setting a new milestone in the global footprint of Chinese valves.

Key Points: 
  • VenusP-Valve, thus, has become the first China-developed heart valvular system to be approved by the FDA for clinical trial, setting a new milestone in the global footprint of Chinese valves.
  • IDE refers to the exemption of medical devices intended for marketing from regulatory requirements, allowing clinical trials to be conducted on such devices.
  • The announced IDE approval will allow VenusP-Valve to initiate pivotal clinical trials in the U.S. to support the Pre-Market Approval (PMA).
  • As the first self-expanding TPVR product approved in China and Europe, VenusP-Valve carries remarkable clinical value.

New Microbiology and Chemistry Laboratory Opens to Accelerate Scientific Discovery

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Wednesday, July 5, 2023

The laboratory will enable domestic and international medical device companies to accelerate their research and development by providing testing services in the areas of microbiology, reusable device testing, chemistry, biocompatibility and packaging.

Key Points: 
  • The laboratory will enable domestic and international medical device companies to accelerate their research and development by providing testing services in the areas of microbiology, reusable device testing, chemistry, biocompatibility and packaging.
  • “The opening of the New Brighton laboratory is a significant milestone for TÜV SÜD and a further addition to our laboratory network around the globe.
  • “We are proud to open this new laboratory and to continue our tradition of innovation and excellence in the healthcare industry.
  • Our expert laboratory staff is eager to provide compliant quality results for our medical device testing customers.

New Microbiology and Chemistry Laboratory Gets Accredited under ISO/IEC 17025:2017

Retrieved on: 
Wednesday, May 31, 2023

TÜV SÜD America Inc., a leading provider of certification, auditing and testing services, has been accredited under American Association for Laboratory Accreditation (A2LA) ISO/IEC 17025:2017 Accreditation.

Key Points: 
  • TÜV SÜD America Inc., a leading provider of certification, auditing and testing services, has been accredited under American Association for Laboratory Accreditation (A2LA) ISO/IEC 17025:2017 Accreditation.
  • The laboratory enables domestic and international medical device companies to accelerate their research and development by providing testing services in the areas of microbiology, reusable device testing, chemistry, biocompatibility and packaging.
  • ISO/IEC 17025:2017 is the international standard for testing and calibration laboratories, and it outlines the requirements for the competence, impartiality, and validity of laboratory results.
  • A wide range of testing is covered including Chemistry, Microbiology, Water Testing, Bioburden, Biocompatibility, and Cytotoxicity.