Regulatory Affairs

ARTICLES

Devicemakers Comment on Machine Learning for SaMD

A combination of real-world evidence and periodic reporting to the FDA should be the cornerstone of how the agency regulates AI and machine learning in software as a medical device, Philips said in a comment on the agency’s draft framework document. Read More

USTR Shields Some Devices From China Tariffs

Devices exempted from the tariffs include dental X-ray alignment and positioning apparatuses, multi-leaf collimators of radiotherapy systems, veterinary ultrasound devices and certain components of electrosurgical instruments. Read More

PRODUCTS

Data Integrity – Webinar Recording/Transcript

$287.00
This presentation will explain high-level data integrity concepts, the definition and importance of data integrity, regulatory expectations for preventing data integrity issues, problem areas for data integrity and strategies for detecting potential data integrity issues in your operations. View

Nine-Volume Title 21 CFR Set 2019

$585.00
The federal government has compiled the new 2019 CFR volumes.






View

Wearables and Sensors – Webinar Recording/Transcript

$287.00
The rapidly evolving landscape for wearables and sensors is having a mighty impact. Former FDA staff member Sugato De, MS — Vice President, Parexel International — and regulatory expert Peter Steiger — Vice President, Parexel Informatics — will explain what you need to know and share management strategies to make it all work for your organization View

Cybersecurity & Privacy Risks for Medical Device Companies – Webinar Recording/Transcript

$287.00
Cybersecurity issues are public health issues: Are your devices and processes at risk? View

The EU-MDR Transition: Meeting the CE Mark Deadline

$397.00
The EU-MDR Transition: Meeting the CE Mark Deadline explains how to take advantage of the soft transition to the new regulation. The soft transition allows companies to retain certain aspects of the current CE Mark applications while following new registration requirements, if their notified bodies approve. View

Animal Tissue Use in Medical Devices – Webinar Recording/Transcript

$287.00
Implementing compliant systems for medical devices with animal tissue requires multiple control layers, typically using standards in the ISO 22442 family — some of which are under revision. View

European Medical Device Regulations (EU MDR) - Webinar Recording/Transcript

$287.00
Devicemakers face a market upheaval in the EU. A new set of rules — the Medical Device Regulation (MDR) — will soon supplant the longstanding Medical Device Directive, forever changing how you sell medical devices in EU nations. View

Organizing Data and Document Archives - Webinar Recording/Transcript

$487.00
Are your documents as organized as you think they are? Can you easily put your hands on the documents FDA investigators request? Or are you searching for that needle in a haystack? View

Perform Effective Investigations and CAPAs - Webinar Recording/Transcript

$287.00
The Corrective and Preventive Action (CAPA) process is the heart of any quality management system. And yet, year after year, CAPA violations are the most frequently observed Quality System subsystem cited by FDA regardless of the manufacturers shape or size. View

Secure and Accelerate Product Approvals - Webinar Recording/Transcript

$287.00
Join FDA legal experts Greg Levine, Esq. and Kelly Combs, Esq. as they clarify the advantages of qualifying for an expedited FDA approval program, what it takes to qualify and how to secure the benefits. View
IOM-IMAGECOVER

Investigations Operations Manual 2019

$377.00
The Investigations Operations Manual is the primary policy guide for FDA investigations and directs the conduct of all fundamental field investigational activities. View

Spreadsheet Validation - Webinar Recording/Transcript

$287.00
Perch on the shoulder of an expert to discover potential pitfalls and innovative approaches. Get feedback, resolve pain points and share experiences in real time. View