Quality

ARTICLES

PRODUCTS

Sampling Plans for Quality Audits - Webinar Recording/Transcript

$287.00
Sampling raises questions for the auditor, such as the number of records to sample, counting nonconforming records and limits on acceptance. Dan O’Leary, one of FDAnews’s most popular presenters, will examine the issues in audit sampling and provide the answers you need for planning. View

Medical Device Voluntary Malfunction Disclosure Regulation - Webinar Recording/Transcript

$287.00
The Voluntary Malfunction Summary Reporting Program was finalized in August 2018 and lets manufacturers report certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis instead of the typical 30 days for each individual report. View

Medical Device Cybersecurity Risks & Best Practices - Webinar Recording/Transcript

$287.00
Smart medical devices have underlying cybersecurity and privacy risks. FDAnews has invited global cybersecurity expert Norma Krayem to walk you through the rapidly changing global regulatory landscape and show you new coping strategies. View

Laboratory Developed Tests, In Vitro Diagnostics & Gene Therapies - Webinar Recording/ Transcript

$287.00
In 90 fast-paced minutes attorneys Mike Druckman and Blake Wilson of Hogan Lovells US LLP will provide insights into how under DAIA the framework for LDTs, companion devices and targeted pharmaceutical therapies may change in the near future, and how to start preparing for these changes. View

The 510(k) Process - Webinar Recording/Transcript

$287.00
As medical device software and other technology continue to advance at a rapid pace, the FDA’s regulatory policies and processes are being forced to evolve to keep pace with innovation. View

Brexit and the Impact to Your Global Business Operations - Webinar Recording/Transcript

$287.00
Your international drug and device business is at a crossroads known as Brexit — the withdrawal of the United Kingdom (UK) from the European Union (EU). What can you expect? View

Device Software Development: A Guide to Risk Management Requirements

$397.00
Device Software Development — based on a presentation by quality systems expert Dan O’Leary — is a comprehensive, point-by-point guide to developing software that meets all FDA and international standards for successful market clearance. View

Regulating Digital Health Tools: Understanding the FDA’s New Guidances

$397.00
Regulating Digital Health Tools — based on a presentation by noted regulatory expert Bradley Merrill Thompson — combs through the guidances and sets out the rules devicemakers must follow. View

Understanding ISO 19011:2018 - Webinar Recording/Transcript

$287.00
The rules on device quality auditing are changing. There’s a new ISO 19011:2018 out with a new focus on risk management. View

Medical Device Software and Risk Management - Webinar Recording/Transcript

$287.00
It’s important for everyone involved in device design, cybersecurity and regulation to understand these issues. Dan O’Leary, simplifies the knotty area of FDA and international device regulation. View

Surviving an MDSAP Inspection: A Guide for Devicemakers

$397.00
The prescriptive nature of the MDSAP model makes it relatively easy to prepare for an audit — if you know what to expect. Surviving an MDSAP Inspection provides all the information you’ll need to understand the MDSAP model.  View

Top Tips for Establishing Device Supplier Quality Metrics - Webinar Recording/Transcript

$287.00
You need to take your supplier quality metrics to the next level. The “Second Data Tier” — used in Compliance and Productivity Metrics — allows for stronger problem prevention and risk management of both internal and supplier processes. View