MDSAP Consortium Sparks Debate Over Upcoming Revisions to ISO 13485:2016

International – MDSAP Consortium Sparks Debate Over Upcoming Revisions to ISO 13485:2016

In a letter to the ISO 13485 working group, the Medical Device Single Audit Program (MDSAP) Regulatory Authority Council (RAC) raised concerns over a...
Global spinal fusion devices market poised for growth

International – Global spinal fusion devices market poised for growth

The global spinal fusion devices market is predicted to increase at a 3 percent compound annual growth rate through 2024, according to a Research and...
Surgical Robotics Market Due for a Shake Up?

International – Surgical Robotics Market Due for a Shake Up?

For years, Intuitive has been recognized as the leader of the surgical robotics market. But there are more competitors on the horizon and the...
MDSAP Consortium Sparks Debate Over Upcoming Revisions to ISO 13485:2016

International – ISO 13485 : ISO board seeks feedback on quality systems standard

Executive Summary Device firms don't have to conform to the latest version of ISO 13485 until March 2019, yet the International Organization for Standardization (ISO)...
Saudi Regulators Adjust Timeframes for Medical Device Market Application (MDMA) Submissions

Saudi Arabia – Saudi Regulators Adjust Timeframes for Medical Device Market Application (MDMA) Submissions

EMERGO SUMMARY OF KEY POINTS: The Saudi Food and Drug Authority (SFDA) has announced updates to certain timeframes for Medical Device Market Application (MDMA)...
FDA Flags Violations at Medical Device Firms in Sweden, Canada, Spain, UK

International – FDA Flags Violations at Medical Device Firms in Sweden, Canada, Spain, UK

Device firms in Sweden, Canada, Spain and the UK separately drew four US Food and Drug Administration (FDA) warning letters over good manufacturing practice...
Brazil’s ANVISA Reports Increase in Medical Device Modification Submissions

Brazil – Brazil’s ANVISA Reports Increase in Medical Device Modification Submissions

EMERGO SUMMARY OF KEY POINTS: Brazil’s ANVISA reports progress in meeting review timeframes for medical device and IVD reviews between July and September 2018. ...
MDSAP Consortium Sparks Debate Over Upcoming Revisions to ISO 13485:2016

International – Insights on Upcoming Revisions to ISO 13485

Following the new outcome meeting statement posted Monday by the management committee of the International Medical Device Regulators Forum (IMDRF), Focus obtained insights into upcoming revisions...
5 Innovative Trends of the Future in Healthcare and Medical Device Manufacturing

International – 5 Innovative Trends of the Future in Healthcare and Medical Device Manufacturing

With such fast-paced innovation in medical devices, the requirements of materials are changing. Implantable devices will be capable of monitoring, controlling and administering treatments,...
ISO 14155 Update in 2019: Key Changes for Medical Device Clinical Investigations

International – ISO 14155 Update in 2019: Key Changes for Medical Device Clinical Investigations

EMERGO by UL SUMMARY OF KEY POINTS: The third edition of the ISO 14155 standard for medical device clinical investigations is expected in 2019. ...

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