Your Monthly Download List

Don't miss these technical resources on design validation and human factors, preventing misconnections, implant coatings, and more.

Pixabay

We've put together a list of the latest how-to medtech webcasts and whitepapers available on Qmed. You’ll find expertise on everything from complaint handling and validation to materials, molding, and testing. Click on any of the links below to download a paper or register for a Webinar.

We also share news on upcoming educational offerings at upcoming MD&M and BIOMEDevice events.

And if you’re looking for education on a topic you don’t see, please feel free to let us know at [email protected]. We welcome suggestions from our medtech community.

Webcasts

A Complaint Management Primer: Compliance-Driven Strategies for Effective Complaint Management
Medical device complaint handling continues to be a top reason for FDA 483 observations and warning letters, according to AssurX. In this Webcast, attendees will hear strategies for implementing a complaint management process that facilitates gathering, evaluating, investigating, and remediating complaints from the premarket stage to closure–and what practices to avoid.

Challenges & Emerging Solutions through Micromolding
This webcast from MTD Micromolding explores the challenges designers face when selecting a micromolding vendor due to part design, material selection, tooling designs, molding practices, and metrology.

Podcast

Design Validation VS. Human Factors Validation
In this episode of the Global Medical Device Podcast, host Jon Speer, founder and VP QA/RA of Greenlight Guru, speaks with Mary Beth Privitera, principal, human factors, HS Design, on the differences between human factors and design validation activities.

Whitepapers

Actionable Steps to Eliminate Small-Bore Connector Misconnection
ISO 80369 provides design modifications and improvements that can be made to connectors to prevent misconnections. This whitepaper from Qosina explores three medical device applications of ISO 80369 and discusses the practical steps medical device companies can take for ISO 80369-3 for connectors for enteral applications, ISO 80369-6 for connectors for neuraxial device applications, and ISO 80369-7 for connectors for intravascular or hypodermic applications. It also discusses the common concerns, challenges, and proposed solutions when switching to new connector geometry.

FDA 21 CFR Part 11 for Medical Device Leak Testing
Uson’s new white paper discusses how the features and functionality of leak tester software can help to enable customers to meet the guidelines of 21 CFR Part 11. Using a leak tester that supports compliance with 21 CFR Part 11 makes it possible for medical device manufacturers to move new products into manufacturing quickly and to support the instrument qualification and operational qualification (IQ/OQ) processes with greater efficiency, Uson reported.

Coating Technologies Review: How Orthopedic Implants Get Coated
Orchid Orthopedic Solutions explores the processes used for implant coatings, such as a variety of sintered coatings and plasma-spray coatings. This white paper shares the background, benefits, and limitations of the technologies and discusses potential future developments.

Four Key Areas of Focus in Managing Supply Chain Relationships
Learn how electronics manufacturing services (EMS) providers and OEMs can work together to optimize supply chain management activities to achieve forecast visibility, early involvement in product development, change communication, and issue resolution.

Don't Miss These Upcoming Events:

BIOMEDevice Boston
New England's Premier Medtech Event
May 15-16, 2019

MD&M East
New York City
The East Coast's Leading Medtech Event
June 11-13, 2019

MD&M Minneapolis
The Midwest's Largest Medtech Event
October 23-24, 2019

BIOMEDevice San Jose
Connecting Silicon Valley’s brightest medtech professionals and latest medical device technologies
December 4-5, 2019

 

Daphne Allen

Daphne Allen is editor-in-chief of MD+DI. She previously served as executive editor of Pharmaceutical & Medical Packaging News, which serves as the pharmaceutical and medical device channel of Packaging Digest. Daphne has covered medical device manufacturing, packaging, labeling, and regulatory issues as well as pharmaceutical packaging and labeling for more than 20 years. She is also a member of the Institute of Packaging Professionals's Medical Device Packaging Technical Committee. Follow her on Twitter at @daphneallen.

 

500 characters remaining