ISO 13485

CSOFT Health Sciences Opens Medical Market Research Center to Support Pharmaceutical & Clinical Industry Growth

Retrieved on: 
Wednesday, March 31, 2021
Clinical research, Clinical data management, Health sciences, Health, Life sciences, Pharmaceutical industry, Electronic common technical document, Validity, Medical translation, ISO 13485, Validation

SINGAPORE, March 31, 2021 /PRNewswire/ --CSOFT Boston, leaders in medical translation and market access consulting, announce CSOFT Health Sciences Singapore's new Market Research and Business Development Center in Shanghai, extending its support for the growing communication needs of pharmaceutical groups in eastern China's Huadong region.

Key Points: 
  • SINGAPORE, March 31, 2021 /PRNewswire/ --CSOFT Boston, leaders in medical translation and market access consulting, announce CSOFT Health Sciences Singapore's new Market Research and Business Development Center in Shanghai, extending its support for the growing communication needs of pharmaceutical groups in eastern China's Huadong region.
  • Located within Shanghai's Puxi center, CSOFT's newest launch gains immediate proximity to Shanghai's Zhangjiang High-Tech Industrial Development Zone, a region that accounts for 30.4% of Shanghai's pharmaceutical industry market value.
  • CSOFT Health Sciences provides ISO 13485:2016 certified medical translation services to companies throughout the life science industries, with a focus on medical device translation, linguistic validation, CTD/eCTD submissions, and global clinical trials.
  • CSOFT Health Sciences Leaders in Medical Translation provides end-to-end localization services for all phases of the product lifecycle, from pre-clinical to post launch.

Agiliti Acquires Northfield Medical, Inc.

Retrieved on: 
Friday, March 19, 2021
Medical devices, Surgery, Infectious diseases, Hospitals, Finance, Professional services, Practice Management, Other Health, Managed care, Health, Medical equipment, ISO 13485, Medical technology, Medical device, ERT, Surgery, Science and technology, Medicine, Technology, Integrated Medical Systems International, Agiliti, Inc., Northfield Medical, Inc.

Agiliti, Inc., (Agiliti), an essential service provider to the U.S. healthcare industry, announced it has acquired Northfield Medical, Inc., (Northfield Medical), a nationwide provider of surgical equipment repair services, in a stock purchase transaction valued at $475M.

Key Points: 
  • Agiliti, Inc., (Agiliti), an essential service provider to the U.S. healthcare industry, announced it has acquired Northfield Medical, Inc., (Northfield Medical), a nationwide provider of surgical equipment repair services, in a stock purchase transaction valued at $475M.
  • Northfield Medical provides service and repair of medical devices, specializing in the repair of endoscopes, surgical instruments and other operating room equipment.
  • Agiliti, Inc., is an essential service provider to the U.S. healthcare industry with solutions that help support a more efficient, safe and sustainable healthcare delivery system.
  • Northfield Medical, Inc., is a national independent service organization and ISO 13485:2016 certified provider of surgical equipment repair services to the healthcare industry.

Myant's Connected Clothing Brand Skiin Announces Open Beta Launch for Garments Enabling Connected Care

Retrieved on: 
Thursday, March 18, 2021
Human–computer interaction, Clothing, Distributed computing architecture, Wearable devices, Ambient intelligence, Internet of things, Ubiquitous computing, Wearable technology, Bra, Undergarment, Biometrics, ISO 13485

TORONTO, March 18, 2021 /PRNewswire/ --Myant Inc. ( www.myant.ca ), industry leaders in textile computing and ISO 13485 certified medical device manufacturer, and Skiin ( www.skiin.com ), Myant's connected clothing brand, have announced the open beta launch for their collection of smart garments that enable families to care for their loved ones from afar.

Key Points: 
  • TORONTO, March 18, 2021 /PRNewswire/ --Myant Inc. ( www.myant.ca ), industry leaders in textile computing and ISO 13485 certified medical device manufacturer, and Skiin ( www.skiin.com ), Myant's connected clothing brand, have announced the open beta launch for their collection of smart garments that enable families to care for their loved ones from afar.
  • The Open Beta launch is the first time the general public has been invited to purchase and experience the product, now available at an introductory price of $99 USD / $129 CAD for the starter kit.
  • Though many wearable devices are able to track biometrics, adoption of these technologies can be a challenge for elderly users.
  • The collection at launch will include men'sand women's underwear in various styles, while other garments like bras and tank tops will be introduced in the coming months.

Excell Battery Announces ISO 13485 Certification

Retrieved on: 
Wednesday, March 17, 2021
Engineering, Health, Other Energy, Medical devices, Manufacturing, Alternative energy, Energy, Medical technology, ISO 13485, Medical equipment, Technology, Science and technology, Electric power, Medical device, Battery pack, Electric battery, Electrical engineering, SGS, Excell Battery

Excell Battery is pleased to announce that it has received ISO 13485:2016 certification from SGS ( www.sgs.com ) for the design and manufacture of battery packs for medical device applications.

Key Points: 
  • Excell Battery is pleased to announce that it has received ISO 13485:2016 certification from SGS ( www.sgs.com ) for the design and manufacture of battery packs for medical device applications.
  • This achievement is a significant milestone for Excell Battery and further confirms the safety and reliability of its medical battery system design and supply for medical devices and equipment.
  • "We're very excited to receive ISO 13485:2016 medical certification, which ensures that our full end-to-end value chain is performing at the highest standard from a safety quality perspective," said Ian Kane, CEO of Excell Battery.
  • We deliver a broad range of battery solutions that integrate our smart battery technology with cells from our top global partners.

Biomed Diagnostics Viral Transport Media for COVID-19 Now Available

Retrieved on: 
Monday, March 8, 2021
Medicine, Health, Medical equipment, Quality management, Quality management system, Medical device, ISO 13485, Severe acute respiratory syndrome, Food and Drug Administration, Coronavirus disease

Biomed has significantly increased production volume of two transport media devices:VTM-C19 and Saline Solution (.85%).Both formulations have been validated for the safe transport and preservation of specimens from patients being tested for SARS-CoV-2 (COVID-19), influenza A, and RSV.

Key Points: 
  • Biomed has significantly increased production volume of two transport media devices:VTM-C19 and Saline Solution (.85%).Both formulations have been validated for the safe transport and preservation of specimens from patients being tested for SARS-CoV-2 (COVID-19), influenza A, and RSV.
  • Both VTM-C19 and Saline Solution (.85%) are manufactured by Biomed in their ISO 13485:2016 compliant, FDA-registered production facility, in Oregon, USA.
  • Both are available through the US and Canada, listed with the FDA and Health Canada.
  • Biomed Diagnostics operates in compliance with FDA Quality System (QS) Regulation/Medical Device Good Manufacturing Practices (21 CFR, Part 820) in the manufacture of all products.

Two Day Online Medical Device Regulation Seminar: Lead Auditor EN ISO 13485:2016 and EU MDR 2017/745 - March 8-9, 2021 - ResearchAndMarkets.com

Retrieved on: 
Wednesday, March 3, 2021
Medical devices, Health, Medical technology, ISO 13485, Medical equipment, Medicine, Technology, Regulation (EU) 2017/745, MDR

How to create a clinical evaluation compliant to the EU MDR 745/2017 and the expectations of auditors.

Key Points: 
  • How to create a clinical evaluation compliant to the EU MDR 745/2017 and the expectations of auditors.
  • The interfaces between EN ISO 13485:2016 clause 0 - 4 and EU MDR 745/201 The EN ISO 13485 references 37 times the MDR.
  • The interfaces between EN ISO 13485:2016 clause 5 - 8 and EU MDR 745/2016 The EN ISO 13485 references 37 times the MDR.
  • How to understand the references and what are the required activities according to the standard and the MDR.

DGAP-News: DEBx Medical Receives CE Mark Clearance and ISO 13485 Certification for Debrichem(R), a Novel Desiccant Gel for Chemical Debridement to Initiate Healing in Infected, Chronic Wounds

Retrieved on: 
Thursday, February 25, 2021
Medicine, Branches of biology, Clinical medicine, Debridement, Chronic wound, ISO 13485, Wound, Necrosis, Debrichem, DEBx Medical

DEBx Medical Receives CE Mark Clearance and ISO 13485 Certification for Debrichem(R), a Novel Desiccant Gel for Chemical Debridement to Initiate Healing in Infected, Chronic Wounds

Key Points: 
  • DEBx Medical Receives CE Mark Clearance and ISO 13485 Certification for Debrichem(R), a Novel Desiccant Gel for Chemical Debridement to Initiate Healing in Infected, Chronic Wounds
    The issuer is solely responsible for the content of this announcement.
  • Debrichem can now carry the CE mark for a medical device class IIb and has also been awarded ISO 13485:2016 certification.
  • Debrichem is a topical desiccant gel for chemical wound debridement used for the treatment of chronic infected and/or necrotic wounds.
  • Debrichem offers a disruptive approach to debridement that has been demonstrated to enable healing of chronic wounds in more than 90 % of cases.

DEBx Medical Receives CE Mark Clearance and ISO 13485 Certification for Debrichem®, a Novel Desiccant Gel for Chemical Debridement to Initiate Healing in Infected, Chronic Wounds

Retrieved on: 
Thursday, February 25, 2021
Medicine, Branches of biology, Clinical medicine, Necrosis, Chronic wound, Debridement, ISO 13485, Wound, Wound bed preparation, Draft:Flen Health

Debrichem can now carry the CE mark for a medical device class IIb and has also been awarded ISO 13485:2016 certification.

Key Points: 
  • Debrichem can now carry the CE mark for a medical device class IIb and has also been awarded ISO 13485:2016 certification.
  • Debrichem is a topical desiccant gel for chemical wound debridement used for the treatment of chronic infected and/or necrotic wounds.
  • Debrichem, DEBxMedicals first product, received a CE mark in early 2021 and will be launched in markets around the world.
  • Debrichem offers a disruptive approach to debridement that has been demonstrated to enable healing of chronic wounds in more than 90% of cases.

NeuroServo receives certification for its EEG device and for the company as a medical manufacturer

Retrieved on: 
Monday, February 22, 2021
Branches of biology, Medicine, Biology, Medical technology, Medical equipment, ISO 13485, Electroencephalography, Medical device, 60601

MONTREAL, Feb. 22, 2021 /PRNewswire-PRWeb/ --NeuroServo, an early stage medical device company developing an advanced portable and wireless prefrontal EEG announced today that the company received ISO 13485:2016 certification for its R&D and production facilities in Montral.

Key Points: 
  • MONTREAL, Feb. 22, 2021 /PRNewswire-PRWeb/ --NeuroServo, an early stage medical device company developing an advanced portable and wireless prefrontal EEG announced today that the company received ISO 13485:2016 certification for its R&D and production facilities in Montral.
  • This certification is an internationally recognized quality standard to ensure the consistent design, development, production, installation and sale of medical devices that are safe for their intended purposes.
  • In January 2021, NeuroServo received the IEC/EN 60601 and 80601-2-26 certifications for VEEGix, its next-gen EEG.
  • "These are two major milestones for our startup that now becomes a certified medical grade manufacturer with a medical grade device," said Nicolas Tremblay, President.

Nicolle Cannon to Host Quarterly Webinar Series on Electronic Quality Management Systems

Retrieved on: 
Friday, February 19, 2021
Quality management, Medical technology, Quality management system, ISO 13485, Management system, Technology, Science and technology, Articles

DANVILLE, Calif., Feb. 19, 2021 /PRNewswire/ --Cannon Quality Group (CQG), a leading provider of compliant Quality Management solutions to the medical device, Medtech, life sciences, biotech, and IVD industries, has announced that its CEO and founder Nicolle Cannonwill be hosting a quarterly interactive webinar series on the selection and successful implementation of an electronic quality management systems (eQMS).

Key Points: 
  • DANVILLE, Calif., Feb. 19, 2021 /PRNewswire/ --Cannon Quality Group (CQG), a leading provider of compliant Quality Management solutions to the medical device, Medtech, life sciences, biotech, and IVD industries, has announced that its CEO and founder Nicolle Cannonwill be hosting a quarterly interactive webinar series on the selection and successful implementation of an electronic quality management systems (eQMS).
  • In this series, Cannon will feature a particular eQMS vendor, do a light demo and discuss the latest rollouts and product features.
  • "In 2021, we will see an increased adoption of electronic quality management systems (eQMS), as well as a bit of a paradigm shift.
  • The company helps startups set up their first quality management systems, achieve compliance to FDA standards and ISO 13485.