Quality

ARTICLES

New ISO Standard Updates Luer Connector Design

The International Organization for Standardization has released a standard that specifies design and performance requirements of small-bore Luer connectors used in intravascular applications or hypodermic connections in medical devices and accessories. Read More

PRODUCTS

Biocompatibility for Medical Devices - Webinar CD/Transcript

$287.00
Translating government gobbledygook into English is no small task. And the FDA isn’t the only regulator to worry about. Misinterpret a few words of the EU regs and see how much trouble you’ll land in. View

Medical Device Clinical Evaluation Reports - Webinar CD/Transcript

$287.00
Michelle McDonough — Associate Director, Regulatory and Clinical Affairs, MCRA — discusses the requirements for CERs and their place in supporting new device certification and maintaining certification. She will cover best practices for completing CERs, complying with regulations including the MEDDEV 27/1 Rev 4 guidance. View

Devicemaker’s Guide to the 21st Century Cures Act: Changing the Face of Medical Device Regulation

$397.00
Devicemaker’s Guide to the 21st Century Cures Act tells you what to expect in the coming months, which new provisions are likely to cause trouble and how to get out in front of the changes. View

Device Accessories – Understanding and Implementing the Final Guidance

$287.00
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

$287.00
How can you protect your medical devices from ever-changing cybersecurity threats? Join Nick Sikorski and Robert Mai — both of Deloitte & Touche LLP – 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

Five Case Studies Using the E2500 Approach to Validate Equipment, … - Webinar CD/Transcript

$287.00
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

Device Documentation: A Guide to Managing Four Critical Production Files

$177.00
With Device Documentation: A Guide to Managing Four Critical Production Files you will learn about the required elements in the Device Master Record (DMR), the source of the Device Master Record, the required elements in the Device History Record (DHR) and more. View

Three Phases of QSR-Compliant Equipment Control

$177.00
The next time you walk the manufacturing floor, think about how many pieces of equipment you use for production, how many moving parts they have, and all the ways things could go terribly wrong. View