Electronic Medical Device Reporting | eMDR | AssurX

AssurX BlogQuality, compliance and risk management straight talk for regulated industries.

Opinion: 3 Reasons to Consider SaaS for Quality Management Software

Medical Device Industry FDA Regulated Industries Pharmaceutical Industry Quality Management Regulatory Compliance Management

AssurX BlogQuality, compliance and risk management straight talk for regulated industries.

The Importance of Documenting Enterprise QMS Process Requirements

Energy & Utilities Industry FDA Regulated Industries Regulatory Compliance Management

NERC Reliability Standards Require Centralized Data Management

NERC Compliance Energy & Utilities Industry Regulatory Compliance Management

Take Action for ISO 13485:2016 Certification Preparedness

FDA Regulated Industries Regulatory Compliance Management Risk Management

NERC to Expand CIP Reliability Standards

NERC Compliance Energy & Utilities Industry Regulatory Compliance Management Risk Management

Blog Home TAG: Electronic Medical Device Reporting

All Roads Lead to ISO 13485: The Global Context

In Manufacturing Industries, Medical Device Industry, FDA Regulated Industries, Quality Management, Regulatory Compliance Management

Posted May 5, 2021

All Roads Lead to ISO 13485: The Global Context

As regulations and standards evolve, one trend is continually sharpening in focus. ISO 13485 for medical device quality management systems is becoming the international standard for streamlining [...]

How to Meet New EU MDR Requirements for Vigilance and Reporting

In Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management

Posted December 3, 2020

How to Meet New EU MDR Requirements for Vigilance and Reporting

After a one-year delay due to concerns over a shortage of notified bodies, the new EU Medical Device Regulation (MDR) is set to take effect as of May 26, 2021. The regulations are a departure [...]

Medical Device Manufacturers Warned For CAPA Non-Compliance

In Archives, Medical Device Industry, FDA Regulated Industries, Quality Management, Regulatory Compliance Management

Posted June 13, 2017

Medical Device Manufacturers Warned For CAPA Non-Compliance

Three recent warning letters from the Center for Device and Radiological Health (CDRH) offer a glimpse into ongoing medical device inspection investigative focus. CAPA non-compliance is a top [...]

Turnkey Quality + Compliance Management

IN ONE VERSATILE SYSTEMManage all quality and compliance activities, control risk and streamline workflow with a single easy platform.

REQUEST A LIVE DEMO

Categories

Quality Management Software

AssurX Quality + ComplianceA single versatile software system can improve quality, compliance and streamline workflow.

REQUEST A LIVE DEMO

Request a Live Demo