设计验证(design verification)是以客观证据证明设计输出(规范)符合设计输入(要求)。即回答:“我们设计的产品是否正确?(Did we design the device correctly?)。客观证据的定义是:可以通过观察、测量、测试或其他方法证明为属实的信息。 设计确认(design validation)是通过客观证据证明产品规范(设定的技术要求)符合用户需...
工艺验证是Process Verification的翻译。工艺确认是Process Validation的翻译。也有把它们分别翻译为制造工艺过程验证和确认,或者简称为过程验证和过程确认,或者工艺验证和工艺确认。无论如何翻译,verification总是对应验证,validation总是对应确认,这与设计验证和设计确认的翻译是一致的。 工艺验证是通过审查和提供客观证据来核...
medical device DFSS verification and validationdesign verification process and design change magnitudedevice production process validationIntroduction Design Verification Process Production Process Validation Software Validation Design Validation Summarydoi:10.1002/9780470264003.ch17Basem S. El〩aik...
Although design verification and design validation have very different meanings, it’s easy for professionals to incorrectly interchange the use of the terms. We describe the differences between design verification and validation and show how each is properly utilized throughout the design and development...
Whether you are an embedded software developer or an engineer designing a medical device, software quality is critical. Model-Based Design incorporates verification and validation into the software development workflow. As a result, the software is comprehensively tested and verified before you...
This just-published book is written specifically to help medical device and software engineers, QA and compliance professionals, and corporate business managers better understand and implement critical verification and validation processes for medical device software.ARM Techcon...
Discover BSI Group's medical devices capabilities, offering standards and certifications for medical device safety and performance.
Address Medical Device & Life Science Product Development Challenges with Jama Connect With Jama Connect You Can: Efficiently manage requirements, risks, verification, and validation through Live Traceability™ Quickly align systems engineering disciplines across hardware, software, and bioware product ...
The FDA, EU, NMPA and other key regulators have clearly indicated that cybersecurity must be considered throughout the whole life cycle of the medical device. The primary means of verification and validation of the cybersecurity measures...
In medical device development, two critical stages of the design process are often confused: design verification and design validation. What are their distinct roles in the delivery of quality products, and why are the processes so prone to confusion and collapse? Design verification and design ...