Postmarket Safety

ARTICLES

Hong Kong Issues Warnings for Pacing Leads, Stents, Ventilators

Hong Kong’s Department of Heath issued safety warnings for Boston Scientific Ingevity MRI endocardial pacing leads and Percuflex Urinary Diversion stents, Draeger Medical GmbH Oxylog 3000 and Oxylog 3000plus ventilators, and Brainlab radiation treatment software, all of which may have manufacturing or production defects. Read More

PRODUCTS

Device Accessories – Understanding and Implementing the Final Guidance

$187.00
On Dec. 30, 2016, the FDA-CDRH+CBER issued a final guidance document to describe accessories and — in certain cases — provide a classification pathway. Dan O’Leary explains the approach in the guidance document and gives you the tools you need to determine and document whether any of your products are an accessory. View

FDA’s Guidance on Postmarket Management of Cybersecurity in Medical Devices - Webinar CD/Transcript

$187.00
How can you protect your medical devices from ever-changing cybersecurity threats? Join Russell L. Jones and Nick Sikorski — both of Deloitte & Touche LLP, Life Sciences & Healthcare Sector – Cyber Risk Services — for a discussion on the final guidance on postmarket management of cybersecurity in medical devices which was released in Dec. 2016. View

Using the E2500 Approach to Validate Equipment, Utilities and Facilities - Webinar CD/Transcript

$187.00
The E2500 approach streamlines design qualification by focusing on design and verification of critical aspects of a manufacturing system that affect product quality and patient safety. Implementation is not easy, but worthwhile. Once implemented E2500 can effectively reduce the testing, staffing, costs and time associated with the design-qualification phase of a system’s lifecycle. View

Corrections, Removals and Recalls: A Guide for Devicemakers

$177.00
The Corrections, Removals and Recalls: A Guide for Devicemakers brief sorts it all out for you, defining the key terms and parsing the FDA regulations that govern corrections, removals and recalls. View

New Medical Device and In Vitro Diagnostic Regulation in the EU - Webinar CD/Transcript

$287.00
Join Michael M. Gaba — Life Science Partner, Holland & Knight LLP, USA — and Shayesteh Fürst-Ladani — founder and CEO, SFL Regulatory Affairs & Scientific Communication Ltd., Switzerland — for a discussion on the biggest anticipated changes to the EU and U.S. medical device framework and their impact on global go to market strategies, including the extent to which a company can harmonize its regulatory effort for the global market. View

Corrective Action & Preventive Action for Medical Devices - Webinar CD/Transcript

$287.00
Join industry expert Dan O’Leary as he identifies the most frequently cited steps in the corrective and preventive action processes, explains the issues that warning letters reveal and provides information to avoid these problems. View

Conducting an Internal Audit for Pharmaceutical and Medical Device Companies - Webinar CD/Transcript

$101.00
Internal audits are critical element of your quality management system. Your approach must be both systematic and documented to remain compliant. Information from an internal audit provides management with the knowledge they need to show how effectively the company maintains the quality of the product and their processes. View

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

$287.00
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

$287.00
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

$287.00
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

$287.00
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

$397.00
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