ISO 13485

Advanced Ultrasound Electronics (AUE) Achieves ISO 13485 Certification

Retrieved on: 
Tuesday, January 14, 2020
Medical equipment, Articles, Medicine, Geography of Oklahoma, Quality management, Acoustics, Physical therapy, ISO 13485, Medical technology, Ultrasound, ISO, Medical ultrasound

TULSA, Okla., Jan. 14, 2020 /PRNewswire/ --Advanced Ultrasound Electronics (AUE) has achieved ISO 13485:2016 certification, the culmination of a multi-year improvement and optimization initiative for the Tulsa, OK, company.

Key Points: 
  • TULSA, Okla., Jan. 14, 2020 /PRNewswire/ --Advanced Ultrasound Electronics (AUE) has achieved ISO 13485:2016 certification, the culmination of a multi-year improvement and optimization initiative for the Tulsa, OK, company.
  • "ISO 13485 certification means that AUE has put documented processes and regulations in place to ensure customer satisfaction," explained Jim Carr, Director of Service and International Operations.
  • Founded in 2001, Advanced Ultrasound Electronics' commitment to excellence in quality standards and customer satisfaction has made their 20,000 square foot Tulsa facility a respected international hub for repairs, sales and training for medical ultrasound equipment.
  • AUE also sells new and refurbished ultrasound equipment, sells component parts and provides training to customers throughout the U.S.
    Advanced Ultrasound Electronics is a Preferred Partner with many hospital associations.

Tequity Inc.'s Client, TeleMED Diagnostic Management Inc., has been Acquired by Pluribus Technologies Inc.

Retrieved on: 
Monday, January 13, 2020
Medical technology, ISO 13485, Medical equipment, Pluribus, Articles, Technology, Equipment, Draft:SOC Telemed

TORONTO, Jan. 13, 2020 /PRNewswire/ -- Tequity Inc., a North American boutique Tech M&A advisory firm, acted as the exclusive financial advisor to TeleMED Diagnostic Management ("TeleMED") in their acquisition by Pluribus Technologies Inc. ("Pluribus").

Key Points: 
  • TORONTO, Jan. 13, 2020 /PRNewswire/ -- Tequity Inc., a North American boutique Tech M&A advisory firm, acted as the exclusive financial advisor to TeleMED Diagnostic Management ("TeleMED") in their acquisition by Pluribus Technologies Inc. ("Pluribus").
  • TeleMED is a pioneer and leader in designing and engineering innovative solutions for the electronic management of non-invasive medical test data within a diagnostic environment.
  • "We are pleased to add TeleMED as our third acquisition to our portfolio of companies in the past 9 months," said Richard Adair, CEO of Pluribus Technologies.
  • About TeleMED Diagnostic Management Inc.
    TeleMED an ISO 13485:2003 certified company, has been a pioneer in the development of powerful solutions for managing non-invasive medical diagnostic data.

Colospan Announces FDA Approval of IDE for Intraluminal Bypass Device - an Alternative Approach to Diverting Stoma

Retrieved on: 
Wednesday, January 8, 2020
Medical specialties, Medicine, Stoma, Surgery, ISO 13485, Anastomosis, CG

With this IDE approval in hand, the company will launch its pivotal study for CG-100, a temporary Intraluminal Bypass Device, designed to reduce diverting stoma rates in patients undergoing gastrointestinal resection procedures.

Key Points: 
  • With this IDE approval in hand, the company will launch its pivotal study for CG-100, a temporary Intraluminal Bypass Device, designed to reduce diverting stoma rates in patients undergoing gastrointestinal resection procedures.
  • Diverting stoma is the current suboptimal gold standard used by surgeons today to avoid the clinical consequences of anastomotic leaks in patients undergoing colorectal surgery.
  • CG-100, Colospan's lead product, was developed as an alternative approach to diverting stoma.
  • The company holds a CE mark for CG-100 intraluminal bypass device as well as ISO 13485:2016 certification.

FDAnews Announces -- Postmarket Problems for Medical Devices: The Path to Resolution Workshop Feb. 19-20, 2020 - Atlanta, GA

Retrieved on: 
Saturday, December 21, 2019
Medical technology, Articles, Health, Medicine, Medical device, ISO 13485, ISO 14971, Food and Drug Administration, Quality management system

FALLS CHURCH, Va., Dec. 20, 2019 /PRNewswire-PRWeb/ -- Postmarket Problems for Medical Devices: The Path to Resolution

Key Points: 
  • FALLS CHURCH, Va., Dec. 20, 2019 /PRNewswire-PRWeb/ -- Postmarket Problems for Medical Devices: The Path to Resolution
    When it comes to dealing with postmarket medical device problems, there is no one-size-fits-all solution.
  • With the US, EU and Canada following different sets of rules, knowing the latest regulatory requirements and complaint processes of each is critical
    FDAnews and Ombu Enterprises can help one get more familiar with the regulatory landscape during our two-day workshop in Atlanta this February.
  • During the workshop, attendees will:
    *Discover the similarities and differences among US, EU, and Canadian systems and their process flows and decision points
    *Determine the function of Quality System Regulations (QSR), ISO 13485:2016, ISO 14971:2019, and their national and regional variants
    As a bonus, attendees will also receive a set of Excel workbooks to help follow regulatory paths.
  • Postmarket Problems for Medical Devices: The Path to Resolution

IRRAS Receives Renewed CE Mark for the IRRAflow Catheter

Retrieved on: 
Thursday, December 19, 2019
ISO 13485, Medical equipment, Medical technology, Articles, CE marking, cê, Technology

This CE Mark complements the two CE Marks previously obtained for the IRRAflow system's tube set with digital pump and control unit, and allows IRRAS to once again commercially market the IRRAflow system in the European Union.

Key Points: 
  • This CE Mark complements the two CE Marks previously obtained for the IRRAflow system's tube set with digital pump and control unit, and allows IRRAS to once again commercially market the IRRAflow system in the European Union.
  • The complete IRRAflow CNS System received approval for CE Mark today and will be ready for commercial launch in the EU.
  • In April 2018, IRRAS received an updated ISO 13485:2016 certificate and updated CE Mark approvals for both the control unit and tube set with digital pump in the IRRAflow system, both of which are Class II products.
  • "We are pleased to receive the final CE Mark for IRRAflow in Europe, which is a strategically important geography for IRRAS," said Kleanthis G. Xanthopoulos, Ph.D., President and CEO of IRRAS.

IRRAS Receives Renewed CE Mark for the IRRAflow Catheter

Retrieved on: 
Thursday, December 19, 2019
ISO 13485, Medical equipment, Medical technology, Articles, CE marking, cê, Technology

This CE Mark complements the two CE Marks previously obtained for the IRRAflow system's tube set with digital pump and control unit, and allows IRRAS to once again commercially market the IRRAflow system in the European Union.

Key Points: 
  • This CE Mark complements the two CE Marks previously obtained for the IRRAflow system's tube set with digital pump and control unit, and allows IRRAS to once again commercially market the IRRAflow system in the European Union.
  • The complete IRRAflow CNS System received approval for CE Mark today and will be ready for commercial launch in the EU.
  • In April 2018, IRRAS received an updated ISO 13485:2016 certificate and updated CE Mark approvals for both the control unit and tube set with digital pump in the IRRAflow system, both of which are Class II products.
  • "We are pleased to receive the final CE Mark for IRRAflow in Europe, which is a strategically important geography for IRRAS," said Kleanthis G. Xanthopoulos, Ph.D., President and CEO of IRRAS.

Precision ADM Hires Martin Lavoie and Dr. Philippe Dupuis to Expand Metal Additive Manufacturing Market in Ontario, Quebec & US North East

Retrieved on: 
Wednesday, December 11, 2019
Articles, ISO 13485, Medical equipment, Medical technology, AS9100, Advanced manufacturing, Technology

Martin Lavoie brings 20 years of experience in the fields of business development, government relations and advanced manufacturing.

Key Points: 
  • Martin Lavoie brings 20 years of experience in the fields of business development, government relations and advanced manufacturing.
  • His expertise in additive manufacturing comes from his early involvement with Canada Makes, Canadas premier network of expertise in additive manufacturing, which he founded while working for Canadian Manufacturers and Exporters (CME).
  • Precision ADM has created a comprehensive Advanced Digital Manufacturing process which includes Design Support, Engineering, Manufacturing and Finishing.
  • Precision ADM possesses ISO 13485:2016, AS9100 Rev D, and ISO 9001:2015 certifications and is headquartered in Winnipeg, Manitoba, Canada.

Wrobel Engineering Achieves ISO 13485 Certification for Medical Device Manufacturing

Retrieved on: 
Wednesday, December 11, 2019
Medical technology, ISO 13485, Medical equipment, Metal fabrication

ISO 13485:2016 is the internationally recognized standard of quality for organizations involved in the manufacturing of Medical Devices.

Key Points: 
  • ISO 13485:2016 is the internationally recognized standard of quality for organizations involved in the manufacturing of Medical Devices.
  • This prestigious achievement ranks Wrobel as one of the world's elite Precision Metal Fabricators for OEMs and CMs in the Medical Industry.
  • Wrobel Engineering provides metal fabrication services to the Medical, Defense, Aerospace, Telecommunications, Marine, Data Storage, and Specialty Commercial industries.
  • Its expanded capabilities and ISO 13485 certification firmly positions Wrobel as a preferred partner to the leading and largest OEMs in the Medical and Defense industries.

SoftServe Completes Successful ISO 13485 Surveillance Audit for Medical Device and Quality Management Systems

Retrieved on: 
Wednesday, December 11, 2019
Articles, Medical technology, ISO 13485, Medical equipment, Technology, Medicine, Quality management system, Verification and validation, Medical device, Quality management, Management system, Regulatory compliance

AUSTIN, Texas, Dec. 11, 2019 /PRNewswire/ -- SoftServe , a leading digital authority and consulting company, has successfully passed the International Organization for Standardization (ISO) 13485:2016 Surveillance Audit, verifying Quality Management Systems (QMS) that conform to specified requirements and objectives set by the standard.

Key Points: 
  • AUSTIN, Texas, Dec. 11, 2019 /PRNewswire/ -- SoftServe , a leading digital authority and consulting company, has successfully passed the International Organization for Standardization (ISO) 13485:2016 Surveillance Audit, verifying Quality Management Systems (QMS) that conform to specified requirements and objectives set by the standard.
  • The ISO 13485:2016 certification covers guidelines for a company's quality management system that demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
  • "The ISO 13485 audit demonstrates to healthcare providers that SoftServe is dedicated to maintaining the highest level of quality, efficiency, and responsiveness of service provision," said Alexander Amelin, SVP, client success at SoftServe.
  • "This successful audit shows our compliance with the standard guidelines and enables us to produce safer and more effective medical devices and software while meeting international regulatory requirements and customer expectations."

SoftServe Completes Successful ISO 13485 Surveillance Audit for Medical Device and Quality Management Systems

Retrieved on: 
Wednesday, December 11, 2019
Articles, Medical technology, ISO 13485, Medical equipment, Technology, Medicine, Quality management system, Verification and validation, Medical device, Quality management, Management system, Regulatory compliance

AUSTIN, Texas, Dec. 11, 2019 /PRNewswire/ -- SoftServe , a leading digital authority and consulting company, has successfully passed the International Organization for Standardization (ISO) 13485:2016 Surveillance Audit, verifying Quality Management Systems (QMS) that conform to specified requirements and objectives set by the standard.

Key Points: 
  • AUSTIN, Texas, Dec. 11, 2019 /PRNewswire/ -- SoftServe , a leading digital authority and consulting company, has successfully passed the International Organization for Standardization (ISO) 13485:2016 Surveillance Audit, verifying Quality Management Systems (QMS) that conform to specified requirements and objectives set by the standard.
  • The ISO 13485:2016 certification covers guidelines for a company's quality management system that demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
  • "The ISO 13485 audit demonstrates to healthcare providers that SoftServe is dedicated to maintaining the highest level of quality, efficiency, and responsiveness of service provision," said Alexander Amelin, SVP, client success at SoftServe.
  • "This successful audit shows our compliance with the standard guidelines and enables us to produce safer and more effective medical devices and software while meeting international regulatory requirements and customer expectations."