MDSAP

TÜV SÜD Global Risk Consultants (GRC) Updates Its Name to TÜV SÜD Risk Consulting

Retrieved on: 
Monday, April 11, 2022
Consulting, Professional Services, Insurance, Finance, Risk, Maritime Industrial Services, Economic union, ISO 9001, Electromagnetic compatibility, NRTL, MDSAP, Product-service system, RIMS, Certification, EMC, ISO 13485, Environment, Pressure, GRC, Conference, CEO, Consultant, ISO 14001, Safety, AS9100, Planned Parenthood Federation of America, Inc. v. Bucci, European Economic Community, European Union competition law, ISO, Solution, News, Efficiency, FDA, Risk assessment, Insurance, SCC, Risk management, Public relations

Since TV SD acquired TV SD Global Risk Consultants (GRC) a few years ago, we have been working together and striving to deliver the high-quality value-added service to our clients.

Key Points: 
  • Since TV SD acquired TV SD Global Risk Consultants (GRC) a few years ago, we have been working together and striving to deliver the high-quality value-added service to our clients.
  • Being part of TV SD enables us to offer a broader spectrum of risk assessment and related services globally.
  • Having achieved full internal integration, we are pleased to announce that TV SD Global Risk Consultants will update its brand name at the end of 2022, and be known as TV SD Risk Consulting.
  • The Industry Services division also includes TV SD Risk Consulting, the leading global provider of unbundled property loss control services.

Peter Linn Joins TÜV SÜD Risk Consulting as Vice President, Risk Engineering Services

Retrieved on: 
Wednesday, April 6, 2022
Other Manufacturing, Finance, Consulting, Packaging, Engineering, Chemicals, Plastics, Professional Services, Manufacturing, Risk, Golf, Maritime Industrial Services, Music, P&C, Mocha, Economic union, ISO 9001, Electromagnetic compatibility, NRTL, Multimedia, McLennan, AXA, Risk management, MDSAP, Product-service system, RIMS, Certification, EMC, ISO 13485, Ageing, Environment, Pressure, CEO, Marsh, ISO 14001, Industry, Safety, Marsh McLennan, AS9100, Hayward v Zurich Insurance Company plc, Peter Marsh, FORCE America, Inc., European Union competition law, European Economic Community, Running, Solution, Fusion Global Business Solutions, ISO, Efficiency, Foodservice, FDA, SCC, Partnership, Online gambling, Carrier, Broker

We are pleased to announce that effective April 1, 2022, Peter Linn has joined TV SD Risk Consulting as Vice President, Risk Engineering Services.

Key Points: 
  • We are pleased to announce that effective April 1, 2022, Peter Linn has joined TV SD Risk Consulting as Vice President, Risk Engineering Services.
  • View the full release here: https://www.businesswire.com/news/home/20220406005168/en/
    TV SD is pleased to announce that effective April 1, 2022, Peter Linn has joined TV SD Risk Consulting as Vice President, Risk Engineering Services.
  • Jim Marsh, President and CEO of TV SD Risk Consulting shared: We are happy to have Peter Linn join us.
  • The Industry Services division also includes TV SD Risk Consulting, the leading global provider of unbundled property loss control services.

PDO Max® Continues to Successfully Earn Medical Device Single Audit Program Certification

Retrieved on: 
Tuesday, April 5, 2022
Skin, MDSAP, Certification, Sleep, CEO, Safety, Quality management system, MAX, QR, Founder, FDA, PDO, Medical device

SYRACUSE, N.Y., April 5, 2022 /PRNewswire/ -- PDO Max, Inc., a leader in FDA cleared Polydioxanone (PDO) threads-in-cannula medical devices for non-surgical facial tissue repositioning, is proud to announce that their PDO device continues to comply with TheMedical Device Single Audit Program orMDSAP certification.

Key Points: 
  • SYRACUSE, N.Y., April 5, 2022 /PRNewswire/ -- PDO Max, Inc., a leader in FDA cleared Polydioxanone (PDO) threads-in-cannula medical devices for non-surgical facial tissue repositioning, is proud to announce that their PDO device continues to comply with TheMedical Device Single Audit Program orMDSAP certification.
  • PDO Max is also ISO-13485: 2016 certified, which means they have demonstrated their ability to provide medical devices under very rigorous quality expectations.
  • About: PDO MAX, Inc. is headquartered in Liverpool, NY, and is a female-owned medical device provider for medical aesthetic needs in the U.S. PDO Max is the trusted provider of hundreds of medical practices utilizing its proprietary FDA cleared (K190245) Polydioxanone (PDO) threads- in-cannula.
  • For more information regarding PDO MAX threads, to place an order, or to schedule a training, please contact PDO MAX at 800-670-0225 or visit https://www.pdomax.com .

Wallet Factory Expands it Regional Presence in MEA by Partnering with MDSap

Retrieved on: 
Tuesday, March 22, 2022
Software, Banking, Mobile, Wireless, Networks, Online Retail, Internet, Professional Services, Data Management, Technology, Security, Retail, Finance, MEA, Device file, CEO, Financial technology, B2B, Communication, Midi-Pyrénées, Lead, SAP, United Arab Emirates, Factory, Solution, Satellite navigation, Partnership, Cryptocurrency, Central Europe, WALLET FACTORY, MDSAP

The company has boosted its regional presence in the MEA region through a strategic and exclusive partnership with MDSap, a Gold Partner of SAP and part of the Midis Group that serves enterprise customers in MENA, Turkey and Central Europe.

Key Points: 
  • The company has boosted its regional presence in the MEA region through a strategic and exclusive partnership with MDSap, a Gold Partner of SAP and part of the Midis Group that serves enterprise customers in MENA, Turkey and Central Europe.
  • We are thrilled to partner with MDSap, a leading provider of high quality professional services that implements world-class integrated solutions, said Michael Miro, CEO of Wallet Factory.
  • Wallet Factory has delegated Kirill Zhuchkov, its Chief Business Development Officer, to take the lead in implementing the companys regional sales strategy and facilitating the process of long-term partnership development.
  • We welcome our partnership with Wallet Factory, a leading provider of Mobile financial services offering cutting edge solutions for industries operating in the B2B, B2C sector.

bioLytical Laboratories Inc. Receives its CE Mark for the iStatis COVID-19 Antigen Home Test

Retrieved on: 
Monday, March 21, 2022
Mayo Collaborative Services v. Prometheus Laboratories, Inc., Globe, MDSAP, Research, Privacy, Industry, COVID-19, GLOBE, Patient, Infection, Pharmaceutical industry, Vaccine

RICHMOND, British Columbia, March 21, 2022 (GLOBE NEWSWIRE) -- bioLytical Laboratories Inc. (“bioLytical”), a global leader in rapid in-vitro medical diagnostics, announced today that it is launching its new testing platform, iStatis, across Europe after receiving its CE Mark for the iStatis COVID-19 Antigen Home Test, allowing its immediate entry into the European market.

Key Points: 
  • Building on its innovative INSTI testing platform, bioLytical launched iStatis to continue creating reliable access to testing.
  • We are excited to announce the addition of iStatis in Europe with our new COVID-19 rapid antigen home test, said Rob Mackie, Chief Executive Officer of bioLytical.
  • bioLytical will manufacture the iStatis COVID-19 Antigen Home Tests in its ISO 13485:2016 MDSAP certified facility in Richmond, British Columbia.
  • As a global leader in ultra-rapid infectious disease diagnostics, bioLytical is working to ensure our iStatis COVID-19 Antigen Home Test kits are available across Europe.

bioLytical Laboratories Inc. Receives Health Canada Authorization for its iStatis COVID-19 Antigen Test

Retrieved on: 
Monday, March 7, 2022
Globe, ISO, Infection, Patient, MDSAP, Health Canada, Research, Industry, PCR, Euclidean distance, COVID-19, Health, GLOBE, Pharmaceutical industry, Vaccine

Building on its innovative INSTI testing platform, bioLytical launched iStatis to continue creating reliable access to testing.

Key Points: 
  • Building on its innovative INSTI testing platform, bioLytical launched iStatis to continue creating reliable access to testing.
  • With additional lateral flow technology in its portfolio, bioLytical can reach more people with its COVID-19 antigen test that provides peace of mind with its industry-leading accuracy.
  • We are excited to announce the addition of iStatis with our new COVID-19 rapid antigen test, said Rob Mackie, Chief Executive Officer of bioLytical.
  • bioLytical will manufacture the iStatis COVID-19 Antigen Tests in its MDSAP and ISO 13485-certified facility in Richmond, British Columbia, to sell and distribute across Canada.

Establishment Labs to Present at the Cowen 42nd Annual Health Care Conference

Retrieved on: 
Wednesday, March 2, 2022
Surgery, Health, Medical Devices, Motiva, Conference, 21 CFR 820, Diversified Specialty Institute Holdings, Inc., MDSAP, FDA, ESTA, IDE, Clinical trial, Webcast, NASDAQ, Pharmaceutical industry

Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving womens health and wellness, principally in breast aesthetics and reconstruction, today announced that Juan Jos Chacn-Quirs, Founder and Chief Executive Officer, and Raj Denhoy, Chief Financial Officer, will present virtually at the Cowen 42nd Annual Health Care Conference on Monday, March 7, 2022 at 2:10 pm Eastern Time.

Key Points: 
  • Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving womens health and wellness, principally in breast aesthetics and reconstruction, today announced that Juan Jos Chacn-Quirs, Founder and Chief Executive Officer, and Raj Denhoy, Chief Financial Officer, will present virtually at the Cowen 42nd Annual Health Care Conference on Monday, March 7, 2022 at 2:10 pm Eastern Time.
  • A live webcast of the presentation will be available on the Establishment Labs investor relations website at https://investors.establishmentlabs.com/ .
  • An archived version of the webcast will be available on the same website following completion of the event.
  • Establishment Labs Holdings Inc. is a global medical technology company dedicated to improving womens health and wellness.

BioElectronics Corporation Chairman Richard Staelin, Ph.D., Updates Company Achievements

Retrieved on: 
Monday, February 28, 2022
State University of New York, TKA, GLOBE, Biomedical engineering, Compliance, Chronic pain, COVID-19, State university system, University, Marketing, MDSAP, Letter, Stanford University Medical Center, Industry, Paper, Company, Bioelectronics, University of California, San Francisco, United Kingdom, Safety, Biomedicine, Sale, Review, RCT, United Arab Emirates, PWST, Back pain, FDA, Dog, Bachelor of Science in Biomedical Engineering, University at Buffalo, MBA, Forward-looking statement, Patient, Technology, Zoya, Research, Doctor of Philosophy, Kingdom, History of the University of Maryland, College Park, Management, Pharmaceutical industry, Medical device, Dentistry, Audit, Science, DRS, MD

FREDERICK, MD, Feb. 28, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire BioElectronics Corporation ( https://www.bielcorp.com/ OTC: BIEL) is pleased to update, in a letter from its Chairman, Richard Staelin, Ph.D., new distribution partners, personnel changes, and new clinical research studies.

Key Points: 
  • FREDERICK, MD, Feb. 28, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire BioElectronics Corporation ( https://www.bielcorp.com/ OTC: BIEL) is pleased to update, in a letter from its Chairman, Richard Staelin, Ph.D., new distribution partners, personnel changes, and new clinical research studies.
  • Ms. Sanders has also finalized a contract with Modern Development Medical Company., which will be distributing both RecoveryRx and ActiPatch in Kuwait, Qatar, and Oman.
  • The Company recently promoted Iqra Ikki Anwar-Dean to Director of Operations in recognition of her outstanding past performance.
  • Ms. Anwar-Dean joined BioElectronics as a Marketing Manager in 2016 and earned her MBA from the University of Maryland while working full time.

Establishment Labs Reports Fourth Quarter and Full Year 2021 Financial Results; Record Fourth Quarter Revenue of $35.3 Million

Retrieved on: 
Tuesday, March 1, 2022
Medical Supplies, Medical Devices, Health, Consumer, Surgery, Women, ESTA, Annual report, Aesthetics, US FDA, Revlon, Inc. v. MacAndrews & Forbes Holdings, Inc., Growth, Time, Risk, Securities Exchange Act of 1934, Total, Investment, Security (finance), NASDAQ, MDSAP, Industry, Company, Clinical trial, Investor relations, Environment, Private Securities Litigation Reform Act, List of Nature Research journals, U.S. Securities and Exchange Commission, JOY, Adoption, Woman, US, 21 CFR 820, Science, FDA, IDE, Securities Act of 1933, Harwell Science and Innovation Campus, Marketing, Form 10-K, Goal, PMA, CE, Breast, Video game, Medical device, Cryptocurrency, Pharmaceutical industry, Motiva

Gross profit for the fourth quarter was 68.6% of revenue, compared to 54.3% of revenue for the same period in 2020.

Key Points: 
  • Gross profit for the fourth quarter was 68.6% of revenue, compared to 54.3% of revenue for the same period in 2020.
  • Fourth quarter revenue of $35.3 million was up 31.0% from the fourth quarter of 2020 and full year revenue of $126.7 million was up 50% over the year ago period.
  • Total operating expenses for the fourth quarter were $33.6 million, an increase of $10.9 million compared to $22.7 million in the fourth of 2020.
  • SG&A expenses for the fourth quarter increased approximately $9.4 million to $27.6 million compared to $18.2 million in the fourth quarter of 2020.

Establishment Labs Reaches Two Million Motiva Implants Milestone

Retrieved on: 
Thursday, February 17, 2022
Health, Medical Devices, Consumer, Women, Surgery, Other Health, General Health, NASDAQ, MDSAP, Adoption, Surgeon, Time, Science, Founder, PMS, Establishment, Revlon, Inc. v. MacAndrews & Forbes Holdings, Inc., U.S. Securities and Exchange Commission, Security (finance), Securities Act of 1933, Private Securities Litigation Reform Act, Motiva, Clinical trial, Goal, Safety, Medical Affairs Bureau, Securities Exchange Act of 1934, Environment, Risk, ESTA, IDE, Woman, FDA, Sale, Partnership, 21 CFR 820, Â, Research, Medical device, Risk management

Having over two million Motiva implants now in the market is a testament to those efforts.

Key Points: 
  • Having over two million Motiva implants now in the market is a testament to those efforts.
  • Motiva Implants are part of Establishment Labs comprehensive portfolio of advanced smooth implants that are available in more than 80 countries.
  • The Motiva portfolio includes Motiva Round, Ergonomix, and Ergonomix2 implants, the latter of which are available as part of the JOY program; Motiva MIA, the companys minimally invasive breast enhancement offering; and the Motiva Flora tissue expander.
  • Establishment Labs offers a portfolio of advanced silicone gel-filled breast implants, branded as Motiva Implants that include a number of innovative and patented features designed to deliver improved aesthetic and clinical outcomes.