DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "ISO 13485 2016-Quality management systems - Requirements for regulatory purposes - Webinar" webinar to their offering.

The three-year transition period of ISO 13485:2016 officially comes to an end this month, but that deadline is almost meaningless at this stage. If you’re a medical device OEM doing business ...

RUTHERFORD, N.J., Jan. 21, 2025 (GLOBE NEWSWIRE) -- Glucotrack, Inc. (GCTK) (“Glucotrack” or the “Company”), a medical technology company focused on the design, development, and commercialization of ...

The FDA has notified the medical device manufacturing sector that ISO-13485(2016) will be recognized as a Quality Management System Consensus Standard. In February 2026, the FDA will move away from ...

DUBLIN--(BUSINESS WIRE)--The "An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices Training Course" conference has been added to ResearchAndMarkets.com's offering.

ISO 13485:2016 is designed to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent ...

WINNIPEG, Manitoba, July 17, 2024 (GLOBE NEWSWIRE) -- Kane Biotech Inc. (KNE:CA) (TSX-V:KNE; OTCQB:KNBIF) (“Kane Biotech” or “Kane”) announces that it has received ISO 13485:2016 Medical Device Single ...

Glucotrack, Inc., a medical technology company specializing in diabetes solutions, announced it has achieved ISO 13485:2016 certification from the British Standards Institute, marking a significant ...

BRISBANE, Australia and SEATTLE, Feb. 27, 2020 /PRNewswire/ -- Immunexpress, Pty Ltd & Inc.,a molecular diagnostic company with the first FDA cleared host response assay for suspected sepsis patients, ...

ROCHESTER, Minn., Jan. 30, 2019 /PRNewswire-PRWeb/ -- Ambient Clinical Analytics announces today that it achieved ISO 13485:2016 certification and the Company's DART™ solution was included in the ...

This course covers changes from ISO 13485:2003 to the ISO 13485:2016 standard and their impact on a company’s Quality Management System (QMS). Topics include the Annex SL framework, methods for ...

GUELPH, ON / ACCESSWIRE / May 18, 2023 / Zentek Ltd. ("Zentek" or the "Company") ZTEKZEN, a graphene technology development and commercialization company has been granted ISO 13485:2016 Quality ...