Search Results for QMS

Showing 1 – 8

Preparing for and Managing FDA Inspections By Sharry Arora, Bhaskar Saxena - Published 13 December 2017

The article discusses best practices for a manufacturer to stay 'inspection ready' on a day-to-day basis with a focus on how to prepare for and successfully manage FDA inspections from start to finish.

Categories: Features, US, FDA, Compliance, Drugs, Manufacturing

Tags: Inspections, GxP, Quality Management System, QMS, CAPA, CMC, Validation, Form 483, Quality Assurance

New ISO 13485: Device Companies Have Three Years to Transition By Michael Mezher - Published 01 March 2016

The International Organization for Standardization (ISO) late last month released its long-awaited revision to ISO 13485, the global standard for medical device quality management systems (QMS), which replaces the previous version from 2003.

Categories: News, Japan, Canada, Europe, Oceania, US, ISO, Medical Devices, Quality

Tags: ISO 13485, ISO 13485:2003, ISO 13485:2016, Quality Management Systems, QMS

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

With Eye on Improving Quality, Indian Regulator gets First ISO Certification By Michael Mezher - Published 24 February 2015

India’s regulatory authority has announced that one of its offices has become the first in the country to become certified by the International Organization for Standardization (ISO).

Categories: News, India, CDSCO, ISO, Government affairs

Tags: ISO, International Organization for Standardization, ISO 9001:2008, ISO 9001, Quality Management Systems, QMS

Public Comment Period Opens on ISO 9001, Major Device Quality Standard By Alexander Gaffney, RAC - Published 21 July 2014

The International Standards Organization (ISO), an international group whose standards are widely used in the life sciences industry, has finally released a draft of its latest iteration of the ISO 9001 standard for public consultation.

Categories: News, ISO, In vitro diagnostics, Manufacturing, Medical Devices, Quality

Tags: ISO 9001, QMS, Quality Management System, Consultation, International Standards Organization, ISO

Creating a Culture of Compliance By Susan Mozgai and David Lerner - Published 21 May 2014

In an environment where medical product regulations seem to be expanding continuously, proportional investment in compliance infrastructure and controls runs the risk of diminishing returns. The key to achieving the right balance of commercial success and compliance is to focus on continuous improvement, specifically root-cause analysis.

Categories: Features, Compliance, Quality

Tags: CAPA, Continuous Improvement, QMS, Quality Management System

Seeing the Bigger Audit Picture with an Enterprise Quality Management System By K.R. Karu - Published 18 January 2013

A comprehensive and effective enterprise quality management system (EQMS) allows each audit hierarchy and process to be configured to meet the specific needs and requirements of each unique audit group (GLP, GCP, GMP) while allowing across-the-board analysis.

Categories: Audit


GHTF Proposes New Harmonization of Medical Device Audits By Alexander Gaffney - Published 24 April 2012

Categories: GHTF

Tags: NGS, RAEIF, Nonconformity Grading System, QUality Management System, SG3(PD)/N19, SG3, Standard, Latest News, QMS, proposed, medical device