• There are no items in your cart

AAMI TIR105:2020

Current
Current

The latest, up-to-date edition.

Risk management guidance for combination products
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

09-28-2020

This TIR provides recommendations on the application of risk management principles and processes during development and marketing of combination products that include a device constituent part (drug−device, biological drug−device, or drug−device−biologic), in accordance with FDA’s final rule (21 CFR Part 4) [11]. 4

DocumentType
Standard
ISBN
978-1-57020-770-9
Pages
41
ProductNote
THIS STANDARD ALSO REFERS TO IEC 62366-2:2016,ISO/CD TR 20416
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Current

View more information
US$249.00
Excluding Tax where applicable

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.