Search Results for Quality Management System

Showing 1 – 7

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

MDSAP Changes Aim to Reduce Audit Times By Zachary Brennan - Published 30 October 2017

With an eye on a 1 January 2019 deadline for transitioning to only Medical Device Single Audit Program (MDSAP) quality management system certificates accepted for medical device license applications by Health Canada, the MDSAP consortium has implemented a couple of changes to speed up audits.

Categories: News, Canada, Health Canada, IMDRF, Government affairs, In vitro diagnostics, Medical Devices, Quality

Tags: MDSAP, quality management system audits, medical device audits

How Will ISO 13485:2016 Impact Your Relationship With Suppliers? By Walt Murray - Published 22 November 2016

This article covers how the new ISO 13485 standard affects risk management for suppliers.

Tags: ISO 13485:2016, Quality Management System

How Will ISO 13485:2016 Impact Your Relationship With Suppliers? By Walt Murray - Published 22 November 2016

This article covers how the new ISO 13485 standard affects risk management for suppliers.

Categories: Features, ISO, Manufacturing, Medical Devices

Tags: ISO 13485:2016, Quality Management System

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

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