A manufacturer can then use a change management application to implement changes, internally and throughout the supply chain if necessary. This enables a systematic approach to evaluating the recall and correcting the underlying issue. With an automated QMS, the processes of conducting a recall is no longer punitive, but rather an opportunity to mitigate risk by improving operations and products.

Healthcare organizations are increasingly vulnerable to cyberattacks for information like patient profiles and hospital records.

Regulatory Compliance

There are many constantly changing standards that medical device manufacturers and their suppliers must comply with. Doing so not only helps avoid penalties and fines, but adhering to the required processes inherently reduces risk. Some of those standards and regulations include:

  • ISO 9001: General quality management standards.

  • ISO 13485: Requirements for a quality management system for medical device manufacturers and their suppliers.

  • 21 CFR Part 11: Requirements for FDA-regulated industries for audits, validations, electronic signatures, documentation for software systems, and more.

  • EU Annex 11: Additional requirements to the EC-GMP Guide, specific to computerized systems.

  • ISO 14971: Requirements for the application of risk management to medical devices.

  • MDR EU: Regulatory framework for medical devices for countries in the European Union.

  • MDSAP: Medical device single audit program that recognizes a “global approach to auditing and monitoring the manufacturing of medical devices.”

How Does Software Help? Automated software gives a manufacturer a centralized location for managing everything needed for compliance. Two tools that can help the most are eMDR and audit management.

eMDR. Electronic Medical Device Reporting (eMDR) centralizes how FDA and medical device manufacturers communicate with each other, to address issues of data quality and integrity that came about while reporting serious issues.

With an eMDR tool, manufacturers can submit reports, develop written procedures, maintain files, and designate responsibility for reviving, reviewing, and evaluating complaints to see whether they need further attention. Having an eMDR application within a QMS lets a manufacturer incorporate complaint handling, corrective action, and risk management into all issues. Direct, automated communication with FDA ensures that data is accurate and unaltered, reducing the risk of important issues falling through the cracks.

Audit Management. Audits are often feared, but can actually be opportunities for learning and improvement. More importantly, audits are an important part of achieving and maintaining compliance with ISO standards, FDA regulations and more. Automated software helps a manufacturer stay complaint and reduce organizational risks. It provides a central location to keep audit templates and other documents.

Closing Thoughts

The most recent revision of ISO standards such as ISO 9001 and ISO 13484 have highlighted a common trend of quality management: developing procedures and operations with risk management in mind. Utilizing automated quality management software provides manufacturers with the tools to reduce risk in many key operational areas of medical device manufacturing.

This article was written by Alexa Sussman, Content Marketing Writer for EtQ, Farmingdale, NY. For more information, Click Here .