Postmarket Safety



The 21st Century Cures Act’s Impact on Medical Devices - Webinar CD/Transcript

The passage of the 21st Century Cures Act means you will be scrambling to meet new mandates… regulations and guidances in several key areas — including data development and maintenance, technical support, clinical approvals, breakthrough devices, device inspections and reviews, and humanitarian device exemptions. View

Medical Device Supplier Quality Management - Webinar CD/Transcript

Purchasing controls and supplier management continue to be target-rich environments for FDA investigators. Join expert Jim Shore — Director of Quality at Titan Medical, Inc. — for an overview and up-to-date information on purchasing controls for quality assurance and control of purchased components, services or finished medical devices. View

The Correction and Removals Guidance - Webinar CD/Transcript

It’s been two years since the guidance was published and device manufacturers are still confused about what to do when it comes to corrections and removals. How can you tell the differences between a device enhancement — which is not reported to the FDA — a reportable activity and reporting exceptions? View

Inspection Intelligence: Develop a Data–Driven Approach - Webinar CD/Transcript

To be inspection ready you must understand both the internal and external data affecting your products — and analyze and act on the data. Expert Armin Torres — Principal Software Consultant at Qualified Data Systems — discusses how to make sure that your data — which has come from multiple sources — is internally consistent across the full data set and with your company metrics and KPIs. View

Implementing an 11-Step Plan for Device Software Validation and Verification, 2016 Edition

This updated edition of Implementing an 11-Step Plan for Device Software Validation and Verification contains a new chapter outlining the software validation requirements in ISO 13485:2016. View

Validating the Software That Powers Your Manufacturing Systems and Automated Processes - Webinar CD/Transcript

What does software validation require? Clear thinking… good plans… solid execution… complete records. Industry expert, Dan O’Leary discusses the FDA’s QSR requirements for validation of software used in both production and the quality management system. View

Top Ten Data Integrity Traps: How to Find and Fix Problems

The Top Ten Data Integrity Traps report shows you where most data integrity problems occur and helps you create a plan to weed them out — and keep them out. View

Effective and Efficient Medical Device Recalls - Webinar CD/Transcript

You can’t afford to make mistakes during a recall. Join Willie Bryant and Chris Harvey — both of Stericycle ExpertSOLUTIONS for a discussion on how to assess your current recall plans to see if they’ll really work when you put them into action. View

How Does Cybersecurity Fit in Your QMS? - Webinar CD/Transcript

Learn the best practices for integrating medical security processes with the organization’s QMS and the ongoing role of Quality in securing connected medical devices. View

Inspections — From the Routine to the Truly Bizarre - Webinar CD/Transcript

As you are well aware, even a routine FDA inspection can be problematic — challenging — or truly bizarre. Be prepared to deal with the challenging inspection situations that an FDA inspector may throw your way. View

Medical Device Production and Process Control for Equipment - Webinar CD/Transcript

Production equipment is an often overlooked — but critical — part of an effective QMS. Industry expert, Dan O’Leary discusses how an effective system for production equipment can improve device manufacturing, support a low cost approach and improve equipment operator safety. View

Managing Contract Manufacturers and Testing Labs

Are your contract manufacturers getting you in trouble? Problems with a contract manufacturer or lab can emerge in dozens of unexpected places. From changes in personnel or equipment to faulty SOPs and training, the list can seem impossible to tame. View