The Learning Portal will be under maintenance Monday, 6 December between 6 AM and 5 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

Books Books
The European Medical Device Regulation (2021 Update) (Paperback)
Member: $295.00 Nonmember: $395.00
Your “go-to” EU MDR guide and tool kit intended to be your companion to reference time and time again.
Books Books
Software as a Medical Device (Paperback)
Member: $125.00 Nonmember: $175.00
SaMD will help readers uncover whether their software is subject to global medical device regulations, understand the regulatory implications, and develop their SaMD strategy.
Books Books
Global Medical Device Regulatory Strategy, Second Edition (Hardcover)
Member: $125 Nonmember: $175
Learn to develop a comprehensive global regulatory strategy for medical devices, labeling, clinical, risk management, marketing, and postmarketing.
Books Books
Introduction to the Due Diligence Process, Second Edition (Paperback)
Member: $75.00 Nonmember: $125.00
Explore modern elements of the due diligence process, including the changing focus of document review, and the role of regulatory counsel.
Books Books
The Medical Device Validation Handbook, Second Edition (Hardcover)
Member: $125.00 Nonmember: $175.00
The handbook covers device validation and revalidation throughout the product lifecycle, from design through postmarket.
Books Books
Lifecycle Management Through the Rx-to-OTC Switch (Paperback)
Member: $125.00 Nonmember: $175.00
Lifecycle Management Through the Rx-to-OTC Switch is a must read for anyone involved in or responsible for understanding the regulatory requirements and developmental stages of a successful switch program.
Books Books
Fundamentals of Medical Device Regulations, Fourth Edition (Hardcover)
Member: $295.00 Nonmember: $395.00
Bundle includes the individual medical device subsets from all four Fundamentals of Regulatory Affairs books (US, EU, Canada, international).
Books Books
Fundamentals of Pharmaceutical and Biologics Regulations, Fourth Edition (Hardcover)
Member: $295.00 Nonmember: $395.00
Bundle comprises the pharmaceutical and biologics subsets from all four Fundamentals of Regulatory Affairs books (US, EU, Canada, and international).
     
  •  
  • 1
  •  
  • 2
  •  
  • 3
  •  
  • 4
  •  
  • 5
  •  
  •  

All Results

Books Books

The European Medical Device Regulation (2021 Update) (Paperback)

Member: $295.00 Nonmember: $395.00
Your “go-to” EU MDR guide and tool kit intended to be your companion to reference time and time again.
Books Books

Software as a Medical Device (Paperback)

Member: $125.00 Nonmember: $175.00
SaMD will help readers uncover whether their software is subject to global medical device regulations, understand the regulatory implications, and develop their SaMD strategy.
Books Books

Global Medical Device Regulatory Strategy, Second Edition (Hardcover)

Member: $125 Nonmember: $175
Learn to develop a comprehensive global regulatory strategy for medical devices, labeling, clinical, risk management, marketing, and postmarketing.
Books Books

Introduction to the Due Diligence Process, Second Edition (Paperback)

Member: $75.00 Nonmember: $125.00
Explore modern elements of the due diligence process, including the changing focus of document review, and the role of regulatory counsel.
Books Books

The Medical Device Validation Handbook, Second Edition (Hardcover)

Member: $125.00 Nonmember: $175.00
The handbook covers device validation and revalidation throughout the product lifecycle, from design through postmarket.
Books Books

Lifecycle Management Through the Rx-to-OTC Switch (Paperback)

Member: $125.00 Nonmember: $175.00
Lifecycle Management Through the Rx-to-OTC Switch is a must read for anyone involved in or responsible for understanding the regulatory requirements and developmental stages of a successful switch program.
Books Books

Fundamentals of Medical Device Regulations, Fourth Edition (Hardcover)

Member: $295.00 Nonmember: $395.00
Bundle includes the individual medical device subsets from all four Fundamentals of Regulatory Affairs books (US, EU, Canada, international).
Books Books

Fundamentals of Pharmaceutical and Biologics Regulations, Fourth Edition (Hardcover)

Member: $295.00 Nonmember: $395.00
Bundle comprises the pharmaceutical and biologics subsets from all four Fundamentals of Regulatory Affairs books (US, EU, Canada, and international).
Books Books

Fundamentals of International Regulatory Affairs, Fifth Edition (Hardcover)

Members: $295 Nonmembers: $395
This edition discusses regulatory changes that have occurred globally and technologically with a focus on drugs and medical devices.
Books Books

Regulatory Intelligence 101, Third Edition (Paperback)

Member: $125.00 Nonmember: $175.00
Comprised of 25 chapters from 30 experts from seven different countries, this new edition incorporates a global overview of regulatory intelligence.