Search Results for software as a medical device

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FDA Updates on Digital Health Plans, Software Pre-Certification Pilot By Michael Mezher - Published 27 July 2017

The US Food and Drug Administration (FDA) on Thursday released new details on its plans for regulating digital health technologies, including more information about its upcoming pilot program to pre-certify software-based medical devices.

Categories: News, US, CDRH, Medical Devices, Submission and registration

Tags: Pre-Certification, PreCert Pilot, Software as a Medical Device, SaMD, Digital Health

FDA Pilot to Sign Off on Low-Risk Digital Health Products Without Premarket Review By Zachary Brennan - Published 15 June 2017

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Thursday announced an upcoming pilot program that would create a third-party certification program under which lower-risk digital health products could be marketed without FDA premarket review and higher-risk products could be marketed with a streamlined FDA review.

Categories: News, US, FDA, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: digital health, FDA digital health, software as a medical device

FDA to Create Digital Health Unit By Zachary Brennan - Published 04 May 2017

With ongoing work on guidance related to software as a medical device, and a new dedicated unit to digital health coming to the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), the agency is slowly but surely dipping its toe into the rapidly advancing field.

Categories: News, US, CDRH, Medical Devices

Tags: digital health, software as a medical device, cybersecurity

FDA Releases Guidance on Software as a Medical Device for Consultation By Michael Mezher - Published 13 October 2016

The US Food and Drug Administration (FDA) on Thursday opened a public consultation on a harmonized guidance on the clinical evaluation of software as a medical device (SaMD) developed by the International Medical Device Regulators Forum (IMDRF).

Categories: News, US, FDA, IMDRF, Clinical, Medical Devices

Tags: Software as a Medical Device, SaMD, IMDRF, International Medical Device Regulators Forum

European Commission Offers Guidance on Standalone Software as a Medical Device or IVD By Zachary Brennan - Published 17 August 2016

The European Commission is offering guidance for device companies and other stakeholders trying to determine if their standalone software should be considered a medical device, in vitro diagnostic (IVD) or neither.

Categories: News, Europe, EC, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: standalone software as a medical device, European Commission guidance

IMDRF Proposes QMS Principles for Software as a Medical Device By Michael Mezher - Published 08 April 2015

In recent years, general-purpose devices such as personal computers, smartphones and wearables have enabled the proliferation of “software as a medical device” (SaMD) products.

Categories: News, GHTF, IMDRF, ISO, Manufacturing, Medical Devices, Project management, Quality

Tags: Software as a Medical Device, SaMD, ISO 13845:2003, QMS

AHWP Finalizes Document Meant to Form Backbone of Software Regulation Approach By Alexander Gaffney, RAC - Published 31 October 2014

The medical-device focused Asian Harmonization Working Group (AHWP) has released a new document meant to eventually help provide a common approach for the regulation of medical device software.

Categories: News, Africa, Asia, Middle East, Medical Devices

Tags: AHWP, SaMD, Software, Software as a Medical Device, White Paper, Asian Harmonization Working Party

AHWP Proposes Regulating Health Software as Medical Devices, With Eye to Harmonization By Alexander Gaffney, RAC - Published 09 June 2014

The Asian Harmonization Working Party (AHWP), a regulatory group focused on the harmonization of regulations across Asia and various other emerging economies, has released for comment a new white paper regarding medical device software regulation in which it proposes the future regulation of software as a medical device (SaMD).

Categories: News, Asia, Medical Devices

Tags: AHWP, SaMD, Software as a Medical Device, Software, Medical Software, Mobile Medical Applications, Mobile Apps

IMDRF Proposes Framework for Regulating Device Software, Auditing Organizations By Alexander Gaffney, RAC - Published 02 April 2014

Categories: IMDRF, Audit

Tags: SaMD, MDSAP, Software, Latest News, medical device