Postmarket Safety

ARTICLES

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Transforming the Medical Device Critical Process Supply Chain - Webinar CD/Transcript

$287.00
Now, FDAnews has brought together two MedAccred thought leaders (from J&J and Stryker), plus a MedAccred suppler (Global Technologies) for presentation introducing you to this innovation in supply-chain auditing. View

Cybersecurity and Risk Management for Medical Devices - Webinar CD/Transcript

$287.00
If your medical devices incorporate software, they may be targets for cyber-crooks. It’s time you adopted a strategy to gain information, evaluate it, and take action — including regulatory responsibilities. This FDAnews presentation provides the regulatory information you need to stay compliant. View

FDA’s Work Plan ... the 21st Century Cures Act ... and You - Webinar CD/Transcript

$287.00
The 21st Century Cures Act is a mega-complex set of compromises that Congress mandated. Right now, behind closed doors, the FDA is figuring out how to implement it. Every FDA-regulated health sciences company will be affected. View

Using CDRH’s Medical Device Quality Data to Improve Your Bottom Line - Webinar CD/Transcript

$287.00
The “CY2016 Annual FDA Medical Device Quality System Data” report is an information goldmine for devicemakers — a key to better inspection outcomes as well as greater quality in manufacturing. View

Complaint Management for Devicemakers: From Receiving and Investigating to Analyzing Trends

$397.00
Complaint management is essential to a functioning quality management system. Understanding the FDA’s Quality System Regulation isn’t enough — you must also master ISO 13485:2016 and the new EU MDR. They all require devicemakers to conduct trending in some form or another. But none of them tell you HOW. View

Spreadsheet Validation 2017 - Webinar CD/Transcript

$287.00
What if you could perch on the shoulder of an expert on spreadsheet validation ... look on in real time as he highlights potential pitfalls and defines innovative validation approaches ... ask why he does this instead of that ... and get feedback? View

Biological Risk Evaluation and Management for Medical Devices

$397.00
Biological Risk Evaluation and Management for Medical Devices shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards. View

Disinfectant Testing and Validation - Webinar CD/Transcript

$287.00
Keeping cleanrooms clean takes more than soap and water. A lot more. It’s a complicated — but critical — topic for drug, device, biologics and supplement makers, and compounders too. View

Hack-Proofing Medical Devices: Ensuring Product Safety through Cybersecurity

$397.00
Hack-Proofing Medical Devices will show you how to get — and keep — control of your devices’ networked operations. View

Dealing with China’s Regulatory Authorities: Tips for Devicemakers

$177.00
Dealing with China’s Regulatory Authorities lays out the whole regulatory map — explaining which bodies are responsible for which groups of products and activities, what their particular interests are, how to deal with officials at different levels and what personal factors (education level, language, culture) should be taken into account. View

Device Design and Risk Management - Webinar CD/Transcript

$287.00
Medical device design is linked inextricably with risk management. Risk reduction measures become design inputs. Implementation verification, a risk management activity, can work as design verification too. View

Drug or Device? How the 21st Century Cures Act Impacts Combination Products

$397.00
Drug or Device? How the 21st Century Cures Act Impacts Combination Products takes a close look at the FDA’s new authority governing combination products, as well as several new provisions under the 21st Century Cures Act that could usher in a new era of interdisciplinary product reviews at the FDA. View