Medical device regulation

Virtual Training Course: An Introduction to the Medical Device Regulation (November 8-10, 2022) - ResearchAndMarkets.com

Retrieved on: 
Donnerstag, Juli 28, 2022
Education, Training, Health, Medical Devices, European Medical Writers Association, Pharmacovigilance, Medical device regulation, Notified body, CE, Documentation, Legislation, MDR, Medicine, Medical device

The "An Introduction to the Medical Device Regulation Training Course" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "An Introduction to the Medical Device Regulation Training Course" conference has been added to ResearchAndMarkets.com's offering.
  • This seminar provides an invaluable overview of the European Medical Device Regulation (MDR).
  • This event will be of particular interest to all personnel who are new to the medical device industry, all those who intend to place a medical device on the market and anyone who requires an overview of the medical device sector.
  • What is a medical device?

Flat Medical Enters the Vascular Access Medtech Domain with its Newly Acquired MDR Certification and New Medical Advisor

Retrieved on: 
Dienstag, Juli 12, 2022
Clinical professor, Emergency medicine, Safety, Intensive care medicine, Notified body, MDR, Medical device regulation, European Society of Anaesthesiology and Intensive Care, Medtech, CVC, Certification, Patient, BSI, Physician, Congress, Central, Mayo Clinic, Association, Anesthesia, AVA, Medical device

"This is a super exciting achievement for our team with significantly meaningful value," said Shao-Wei Tseng, the Chief Regulatory Officer of Flat Medical.

Key Points: 
  • "This is a super exciting achievement for our team with significantly meaningful value," said Shao-Wei Tseng, the Chief Regulatory Officer of Flat Medical.
  • "As the first Taiwanese Medtech company awarded MDR certification from the BSI, we feel honored to be certified to supply our innovative solution to improve the safety and quality of central venous catheterization procedures."
  • Flat Medical is now organizing a product launch with its local partners in the U.S. and Europe.
  • Flat Medical is a MedTech company that focuses on safety solutions for clinical procedures.

Supplier Management with the new Medical Device Regulation EU MDR 745/2017 - Webinar - ResearchAndMarkets.com

Retrieved on: 
Freitag, Juli 1, 2022
Medical Devices, Health, EN, Union, Medical device regulation, EU, ISO, MDR, National identity cards in the European Economic Area, Medical device, Risk management

The "Supplier Management with the new Medical Device Regulation EU MDR 745/2017" webinar has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Supplier Management with the new Medical Device Regulation EU MDR 745/2017" webinar has been added to ResearchAndMarkets.com's offering.
  • The new medical device regulation EU MDR 745/2017 in the European Union has a lot of new requirements.
  • Both, the ISO standard and the MDR requires for outsourced processes additional activities and be careful with outsourced processes.
  • The webinar will describe the following vital topics:
    Overview about the changes of the EU MDR 745/2017 regarding supplier and outsourced activities.

Allmed becomes the first fully MDR compliant haemodialysis product producer in Europe, the Middle East and Africa (EMEA) region

Retrieved on: 
Mittwoch, Juni 15, 2022
Solution, Unique Device Identification, Safety, Notified body, MDR, BSI, Achievement, Compliance, Quality management system, UDI, Medical device, Medical device regulation, Health, BS, EMEA, Dialysis, QMS, Patient, Group, Certification, EU, MDD

With the certification, Allmed has become the first haemodialysis products producer in the EMEA region to accomplish and certify full MDR compliance on its medical devices.

Key Points: 
  • With the certification, Allmed has become the first haemodialysis products producer in the EMEA region to accomplish and certify full MDR compliance on its medical devices.
  • Becoming the first fully compliant haemodialysis product producer in the EMEA region is a testament to our commitment to delivering high quality, safe solutions to haemodialysis patients, and I am proud of the many months of hard work and commitment by Allmeds Total Quality Management team.
  • This achievement is a testament to their commitment to ensuring innovation remains at the forefront of their product development.
  • Allmed Group is a global producer of end-to-end haemodialysis product solutions.

Mentice AB intends to acquire all assets related to the software solution Ankyras from the Spanish corporation Galgo Medical S.L.

Retrieved on: 
Donnerstag, Juni 9, 2022
Osteoporosis, Precision medicine, Company, Stroke, SEK, Medical device regulation, Aneurysm, Cerebral arteries, Cardiac electrophysiology, CEO, Information, New York City Department of Information Technology and Telecommunications, Solution, Brain, Hospital, Technology, Acquisition, Department, EUR, Intention, Disclosure, Pompeu Fabra University, Galgo, Death, Medical imaging, Pharmaceutical industry, EU

The Acquisition is characterized as a technology acquisition as this solution is in an early phase of its commercialization.

Key Points: 
  • The Acquisition is characterized as a technology acquisition as this solution is in an early phase of its commercialization.
  • However, the solution has been developed for a long time by Galgo and the software Ankyras is patent protected and CE-marked product (Medical Device Regulation MDR) with technology published by Galgo since 2013.
  • Ankyras is an advanced cloud-based analysis solution that allows a physician to plan treatment for a specific patient.
  • This disclosure contains information that Mentice AB is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014).

Mentice AB intends to acquire all assets related to the software solution Ankyras from the Spanish corporation Galgo Medical S.L.

Retrieved on: 
Donnerstag, Juni 9, 2022
Osteoporosis, Precision medicine, Company, Stroke, SEK, Medical device regulation, Aneurysm, Cerebral arteries, Cardiac electrophysiology, CEO, Information, New York City Department of Information Technology and Telecommunications, Solution, Brain, Hospital, Technology, Acquisition, Department, EUR, Intention, Disclosure, Pompeu Fabra University, Galgo, Death, Medical imaging, Pharmaceutical industry, EU

The Acquisition is characterized as a technology acquisition as this solution is in an early phase of its commercialization.

Key Points: 
  • The Acquisition is characterized as a technology acquisition as this solution is in an early phase of its commercialization.
  • However, the solution has been developed for a long time by Galgo and the software Ankyras is patent protected and CE-marked product (Medical Device Regulation MDR) with technology published by Galgo since 2013.
  • Ankyras is an advanced cloud-based analysis solution that allows a physician to plan treatment for a specific patient.
  • This disclosure contains information that Mentice AB is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014).

Implantica publishes Interim Report Q1, January - March 2022

Retrieved on: 
Mittwoch, Mai 11, 2022
Medical device regulation, Investment, MDR, King Edward, King Edward VII Hospital, Organization, FDA, Congress, Lists of people executed in the United States, VP, EHealth, Mobile phone, Pharmaceutical industry

STOCKHOLM, May 11, 2022 /PRNewswire/ -- 

Key Points: 
  • Implantica continued during this quarter to substantially strengthen its organisation on a broad front.
  • Our regulatory and clinical teams have been diligently preparing the extensive RefluxStop PMA application for FDA approval in US.
  • We also continued to expand our presence in our US subsidiary, Implantica Inc.
    Cash and short-term investments as at the end of the period amounted to MEUR 125.7.
  • Implantica will hold a telephone conference on May 11 at 15:00 CET.

Introduction to the Medical Device Regulation Training Course (May 18-20, 2022) - ResearchAndMarkets.com

Retrieved on: 
Dienstag, Mai 3, 2022
Education, Training, Health, Medical Devices, CE, Legislation, Documentation, MDR, Medical device regulation, European Medical Writers Association, Notified body, Pharmacovigilance, Medicine, Medical device

The "An Introduction to the Medical Device Regulation Training Course" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "An Introduction to the Medical Device Regulation Training Course" conference has been added to ResearchAndMarkets.com's offering.
  • This seminar provides an invaluable overview of the European Medical Device Regulation (MDR).
  • This event will be of particular interest to all personnel who are new to the medical device industry, all those who intend to place a medical device on the market and anyone who requires an overview of the medical device sector.
  • What is a medical device?

Impulse Dynamics' Quality Management System Receives Certification Under European Union Medical Device Regulation

Retrieved on: 
Dienstag, März 22, 2022
Heart, LinkedIn, Certification, Regulatory affairs, Medical device, Medical Device Regulation Act, Quality assurance, HF, Compliance, QMS, Medical device regulation, Impulse, CCM, MDR, Quality of life, Documentation, Safety, Medical Devices Directive, Twitter, GLOBE, Union, DEKRA, FDA, Heart failure, Patient, EU, Facebook

MARLTON, N.J., March 22, 2022 (GLOBE NEWSWIRE) -- Impulse Dynamics, a company dedicated to innovative treatments for chronic heart failure, is pleased to announce that it has successfully completed the requirements for certification of its quality management system (QMS) under the new Medical Device Regulation (MDR) (EU 2017/745 ) now in force in the European Union (EU).

Key Points: 
  • MARLTON, N.J., March 22, 2022 (GLOBE NEWSWIRE) -- Impulse Dynamics, a company dedicated to innovative treatments for chronic heart failure, is pleased to announce that it has successfully completed the requirements for certification of its quality management system (QMS) under the new Medical Device Regulation (MDR) (EU 2017/745 ) now in force in the European Union (EU).
  • The Medical Device Regulation (EU 2017/45) went into effect in May of 2021 for all manufacturers, distributors, and users of medical devices in the EU, replacing the prior Medical Device Directive and Active Implantable Medical Device Directive.
  • According to Impulse Dynamics CEO, Simos Kedikoglou, M.D., Our ability to achieve certification of our QMS under the MDR affirms Impulse Dynamics position at the leading edge of medical device design, development, and manufacturing.
  • MDR certification opens the door for Impulse Dynamics to proceed with its plans for new product development and to launch them without delay.

Delcath Systems Achieves Medical Device Regulation Certification for CHEMOSAT® in Europe

Retrieved on: 
Mittwoch, März 2, 2022
Medical device, Mum, Documentation, IIB, Safety, Certification, FDA, Medical device regulation, Sale, Delcath Systems, Mother, EC, MDD, PHP, Liver, MDR, Nasdaq, Melphalan, GLOBE, UDI, EU

NEW YORK, March 02, 2022 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, is pleased to announce that on February 28 its CHEMOSAT Hepatic Delivery System received Medical Device Regulation (MDR) certification under the new European Medical Devices Regulation [2017/745/EU].

Key Points: 
  • NEW YORK, March 02, 2022 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, is pleased to announce that on February 28 its CHEMOSAT Hepatic Delivery System received Medical Device Regulation (MDR) certification under the new European Medical Devices Regulation [2017/745/EU].
  • Since April 2012, Chemosat had been certified under a previous regulation, the Medical Device Directive [2007/47/EC] (MDD), which is being replaced by MDR.
  • Under MDR, CHEMOSATs designation has changed from a Class IIb to a Class lll medical device.
  • Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers.