ISO 13485

Pulse Systems Announces Upgraded ISO 13485:2016 and ISO 9001:2015 Certifications

Retrieved on: 
Wednesday, June 13, 2018
Medical technology, Medical equipment, ISO 13485, Quality management, Health, Technology

CONCORD, Calif., June 13, 2018 /PRNewswire/ -- Pulse Systems announced today that the Company's ISO 13485 and ISO 9001 certifications have been successfully updated to the latest revisions of both standards.

Key Points: 
  • CONCORD, Calif., June 13, 2018 /PRNewswire/ -- Pulse Systems announced today that the Company's ISO 13485 and ISO 9001 certifications have been successfully updated to the latest revisions of both standards.
  • "Our recent upgrade of these widely-recognized ISO quality certifications represents the culmination of significant effort by our entire quality, technical, and operations team," said Herb Bellucci, President and CEO of Pulse Systems.
  • Pulse Systems specializes in rapid turnaround of prototype parts, and can support full production volumes through its ISO 13485:2016 and ISO 9001:2015 certified manufacturing operations.
  • To learn more about Pulse Systems, or to obtain copies of the Company's newly updated ISO certificates, please visit our website at www.pulsesystems.com .

Five Day Medical Device Course: From Concept to CE Marking - London, United Kingdom - July 2nd-6th, 2018

Retrieved on: 
Friday, May 4, 2018
Medicine, Medical technology, Medical equipment, Health, Medical device, CE marking, ISO 13485, Medical software

The "The Medical Device Summer School - From Concept to CE Marking" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "The Medical Device Summer School - From Concept to CE Marking" conference has been added to ResearchAndMarkets.com's offering.
  • This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process.
  • This course has been designed primarily for those who wish to understand the processes involved in bringing a medical device to market.
  • General medical devices as well as Active Implantable, In-Vitro Diagnostic and Drug Device products will be covered throughout the course.

Natera Inc. Announces First Quarter 2018 Earnings Conference Call

Retrieved on: 
Tuesday, May 1, 2018
Medicine, Medical technology, Health, Natera, Clinical Laboratory Improvement Amendments, Medical laboratory, ISO 13485

Natera is a global leader in cell-free DNA testing.

Key Points: 
  • Natera is a global leader in cell-free DNA testing.
  • The mission of the company is to transform the diagnosis and management of genetic diseases.
  • Natera operates an ISO 13485-certified and CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, Calif.
  • Follow Natera on LinkedIn and Twitter .

TUV Nord Awards ISO 13485 Certification to Keneric Healthcare for the Design/Development, Manufacturing and Distribution of Wound Care Products

Retrieved on: 
Thursday, April 26, 2018
Medical technology, Medical equipment, Technology, Health, ISO 13485, Quality management, Quality management system, Medical device, ISO 14971, ISO

ALLEN, Texas, April 26, 2018 /PRNewswire/ --Keneric Healthcare's ISO certification award represents its ability to design, implement, and successfully manage an effective quality management system that meets the requirements of DIN EN ISO 13485: 2012 / EN ISO 13485: 2012 +AC: 2012 - Medical devices - Quality management systems - Requirements for regulatory purposes.

Key Points: 
  • ALLEN, Texas, April 26, 2018 /PRNewswire/ --Keneric Healthcare's ISO certification award represents its ability to design, implement, and successfully manage an effective quality management system that meets the requirements of DIN EN ISO 13485: 2012 / EN ISO 13485: 2012 +AC: 2012 - Medical devices - Quality management systems - Requirements for regulatory purposes.
  • The scope of the ISO certification supports the Design/Development, Manufacturing and Distribution of Wound Care Products.
  • Keneric Healthcare, a global medical device manufacturer, recognized for the development and commercialization of innovative products that improve patient care, increase clinician efficiency and streamline facility expenditures.
  • For information on where to order Keneric Healthcare's product lines, please email [email protected]