MDSAP

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

Retrieved on: 
Tuesday, August 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.

MedReg 2023: Annual Medical Device Regulatory Confex - Where Regulatory Excellence Meets Virtual Engagement - ResearchAndMarkets.com

Retrieved on: 
Friday, August 11, 2023
Medical Devices, Health, DMR, CAPA, USS Medregal (SS-480), Federal Food, Drug, and Cosmetic Act, PM, ISO, Calendar, Lung compliance, DHR, MDSAP, NextGen Healthcare, MDR, PMA, Design controls, VPS, Knowledge, DHF, AM, FDA, US FDA, Safety, Element, Medical device, Powder metallurgy, EU

The "MedReg 2023 - Annual Medical Device Regulatory Confex" training has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • 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 will revolutionize your understanding of medical device regulations.
  • Why should you make MedReg 2023 a priority on your virtual event calendar?
  • Imagine a world where medical device regulations are disregarded-a world where patient safety is compromised.

The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) Training Course - ResearchAndMarkets.com

Retrieved on: 
Wednesday, August 9, 2023
Health, General Health, IVD, Risk management, Surveillance capitalism, TGA, FDA, Health Canada, PMS, MDSAP, Medical device, EU

Case Study: Who Should be a PRRC?

Key Points: 
  • Case Study: Who Should be a PRRC?
  • What does the regulation state?
  • How does an organisation qualify as small or medium?
  • He has an excellent understanding of risk management, Post Market Surveillance (PMS) and vigilance.

NeuroStar Achieves Milestone Regulatory Clearance in South Korea

Retrieved on: 
Monday, July 17, 2023
Major depressive disorder, Depression, Marketing, TMS, Organization, Ministry of Food and Drug Safety, Quality of life, MFDS, OECD, MDSAP, Sale, Ministry, STIM, MDD, Patient, D-8 Organization for Economic Cooperation, Transcranial magnetic stimulation, Health, Neuronetics, Pharmaceutical industry, Food

This marks the first international market where NeuroStar has obtained marketing authorization for the expanded indication and cutting-edge technologies.

Key Points: 
  • This marks the first international market where NeuroStar has obtained marketing authorization for the expanded indication and cutting-edge technologies.
  • The NeuroStar 3.7 platform standardizes the NeuroStar hardware globally and includes advancements designed to streamline a clinician’s workflow, such as a touchscreen display with a biometric fingerprint reader.
  • South Korea was also reported to have the greatest suicide rate among nations of the Organization of Economic Cooperation and Development (OECD)2.
  • As a market leader in TMS within the South Korean market, NeuroStar aims to fill this unmet need and has partnered with distributor DK Healthcare to expand access to NeuroStar TMS.

MasterControl Celebrates EMEA Customers’ Achievements in 2023

Retrieved on: 
Wednesday, June 7, 2023
Marfan syndrome, ISO, Elekta, SALT, MDSAP, European Masters, Transplant, Organization, Klosterfrau Melissengeist, Patient, Digital transformation, International Design Excellence Awards, Conference, Nursing, Pharmaceutical industry

These awards recognise MasterControl customers who have excelled in quality and manufacturing innovation and are leaders in their respected professions.

Key Points: 
  • These awards recognise MasterControl customers who have excelled in quality and manufacturing innovation and are leaders in their respected professions.
  • De Koning has been an influential leader in quality management working closely with IT to make certain they are using MasterControl and other technology to its full potential.
  • By using MasterControl Insights, Klosterfrau is able to easily generate reports across different sites, saving time and increasing visibility across operations.
  • “Each one of these organizations are positively impacting patient lives and MasterControl is honored to be a partner to these amazing companies and individuals.”

Tasso Recommended for Certification from Medical Device Single Audit Program (MDSAP)

Retrieved on: 
Thursday, May 18, 2023
Health, FDA, Medical Devices, Hospitals, Manufacturing, Other Manufacturing, Biotechnology, International medical graduate, Patient, CE marking, Medicines and Healthcare products Regulatory Agency, Food and Drug Administration, Therapeutic Goods Administration, Ministry of Health, Labour and Welfare, Doctor of Philosophy, MDSAP, Certification, Organization, Medical device, Health Canada, Food

Tasso, Inc., the leading provider of patient-centric, clinical-grade blood collection solutions, today announced that it has been recommended for certification from the Medical Device Single Audit Program (MDSAP), under which a single regulatory audit of a medical device manufacturer may satisfy the requirements of multiple regulatory jurisdictions participating in the program.

Key Points: 
  • Tasso, Inc., the leading provider of patient-centric, clinical-grade blood collection solutions, today announced that it has been recommended for certification from the Medical Device Single Audit Program (MDSAP), under which a single regulatory audit of a medical device manufacturer may satisfy the requirements of multiple regulatory jurisdictions participating in the program.
  • The certification confirms Tasso’s compliance with the standards and regulatory requirements of Australia, Canada and the United States, opening potential new global markets for Tasso.
  • Once received, the certification also can streamline the process of reaching additional markets covered under the MDSAP, including Brazil and Japan.
  • The MDSAP program is part of the International Medical Device Regulators Forum.

Regen Lab Announces the Obtention of the New CE Certification Under Medical Device Regulation (EU MDR 2017/745) Validating the Safety and Performance of Its Proprietary Best-in-class PRP Solutions, Alone or Combined With Hyaluronic Acid

Retrieved on: 
Monday, May 15, 2023
Research, Medical Devices, Engineering, Manufacturing, Biotechnology, Other Health, Health, Other Science, Science, CE, BSI, Medical device, Platelet-rich plasma, Public, HA, MDSAP, Technical documentation, Certification, Hyaluronic acid, MDR, MDD, PRP, Patient, European, Patient safety, Quality assurance, European Medical Devices Industry Group, Medical Device Regulation Act, Safety, Le Mont-sur-Lausanne, Syringe, Foodservice, EU

REGENKIT® is a preparation of Platelet-Rich Plasma (PRP), CELLULAR MATRIX fig®, a combination of PRP and Hyaluronic Acid (HA), and Arthrovisc®, HA filled syringes.

Key Points: 
  • REGENKIT® is a preparation of Platelet-Rich Plasma (PRP), CELLULAR MATRIX fig®, a combination of PRP and Hyaluronic Acid (HA), and Arthrovisc®, HA filled syringes.
  • These EU regulations on medical devices aim at establishing a modern and more robust regulatory framework to protect public health and patient safety.
  • The certifications obtained reinforces Regenlab’s competitive position in the PRP market alone and in combination with HA.
  • Regen Lab is a vertically integrated group with extensive R&D, regulatory and manufacturing expertise.

Implantica publishes Interim Report January - March 2023 (Q1)

Retrieved on: 
Friday, May 12, 2023
CE, Medicine, Corporate Affairs, Admirals (company), Society, AKH, Registry, University, ISO, AFS, Nissen fundoplication, Journal of Medical Economics, MDSAP, Ethics committee, PPI, Ethics, Patient, Magnetism, Habitat for Humanity, Center of excellence, CFO, Medical device, Inselspital

VADUZ, Liechtenstein, May 12, 2023 /PRNewswire/ --

Key Points: 
  • The first RefluxStop™ surgeries have been performed in Spain as we continue to prepare for the public tender process.
  • Another major German Reflux Center, Klinikum Aschaffenburg, completed first RefluxStop cases and also signed up for the Registry study.
  • Implantica has been selected as one of 50 Admired Companies to Watch 2023 by CIO Bulletin.
  • Implantica will hold a teleconference with Peter Forsell (CEO), Andreas Öhrnberg (CFO) and Nicole Pehrsson (Chief Corporate Affairs Officer & Investor Relations).

Neuronetics Receives MDSAP Certification and CE Mark Certification under New MDR

Retrieved on: 
Monday, May 8, 2023
Marketing, CE marking, Quality of life, MDSAP, Medical device regulation, Certification, STIM, MDR, Patient, Patient safety, European, Medical device, European Medical Students' Association, EU, Neuronetics

The Company has received CE Mark Certification for NeuroStar Advanced Therapy under the new Medical Device Regulation (MDR) in the European Union (EU) and the Medical Device Single Audit Program (MDSAP) certification.

Key Points: 
  • The Company has received CE Mark Certification for NeuroStar Advanced Therapy under the new Medical Device Regulation (MDR) in the European Union (EU) and the Medical Device Single Audit Program (MDSAP) certification.
  • The process is designed to improve patient safety and ensure the effectiveness and quality of medical devices sold in the EU.
  • The CE Mark is a symbol that indicates conformity with EU regulations, and it is a mandatory requirement for medical devices to be sold in the EU.
  • MDSAP certification covers distribution in five countries, including the U.S., Japan, Canada, Australia, and Brazil.

ISMART Developments first to receive EU-MDR certification for home use LED device

Retrieved on: 
Thursday, April 27, 2023
Medical device, Medical Devices Directive, Light, Acne, Sue, Medical Device Regulation Act, MDSAP, Medical device regulation, Certification, MDR, LED, MDD, European Medical Devices Industry Group, Glycine mollis, TGA, Health, FDA, Health Canada, Safety, EU

BIRMINGHAM, England, April 27, 2023 /PRNewswire/ -- ISMART Developments Ltd (Birmingham, UK) the leader in flexible non-invasive Light emitting Diode (LED) technology announced that they received certification to European Council Medical Device Regulation 2017/745 for their LED acne facemask.

Key Points: 
  • BIRMINGHAM, England, April 27, 2023 /PRNewswire/ -- ISMART Developments Ltd (Birmingham, UK) the leader in flexible non-invasive Light emitting Diode (LED) technology announced that they received certification to European Council Medical Device Regulation 2017/745 for their LED acne facemask.
  • Granted on March 9th, 2023, ISMART Developments Ltd believe they are the first LED device for home use to receive the certification.
  • Sue D'Arcy Chief Executive Officer of ISMART Developments Ltd spoke about the importance of this company milestone.
  • The European Medical Device authorities have been moving from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) in a bid to protect the health and safety of EU citizens.