Europe Europe
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
Europe Europe
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
Europe Europe
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
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
Europe Europe
The European In Vitro Diagnostic Regulation (Paperback)
Member: $295.00 Nonmember: $395.00
RAPS has teamed up with Meddev Solutions to offer a practical guide to implementing the EU IVDR.
Europe Europe
Books Books
Essentials of Healthcare Product Labeling (Paperback)
Member: $125.00 Nonmember: $175.00
Learn details on labeling for the full lifecycle of human healthcare products, from target labeling through submission and marketing in the US, EU and Canada.
Books Books
Risk Management Principles for Devices and Pharmaceuticals (Hardcover)
Member: $125.00 Nonmember: $175.00
Expanded and updated risk management information on healthcare products around the world.
Books Books
Complete WHO Guidance Documentation Bundle
Member: $15.00 Nonmember: $22.50
A WHO bundle with six guidance documents addressing pharmaceuticals, medical devices, psychotropic substances and plasma.
     
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All Results

Europe Europe
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
Europe Europe

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
Europe Europe

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

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
Europe Europe

The European In Vitro Diagnostic Regulation (Paperback)

Member: $295.00 Nonmember: $395.00
RAPS has teamed up with Meddev Solutions to offer a practical guide to implementing the EU IVDR.
Europe Europe
Books Books

Essentials of Healthcare Product Labeling (Paperback)

Member: $125.00 Nonmember: $175.00
Learn details on labeling for the full lifecycle of human healthcare products, from target labeling through submission and marketing in the US, EU and Canada.
Books Books

Risk Management Principles for Devices and Pharmaceuticals (Hardcover)

Member: $125.00 Nonmember: $175.00
Expanded and updated risk management information on healthcare products around the world.
Books Books

Complete WHO Guidance Documentation Bundle

Member: $15.00 Nonmember: $22.50
A WHO bundle with six guidance documents addressing pharmaceuticals, medical devices, psychotropic substances and plasma.
Books Books

International Combination Products (Paperback)

Member: $125.00 Nonmember: $175.00
This book provides an in-depth look at this breakthrough field and covers three major regulatory regions – the US, Canada, and Europe.
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.