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MedicalDevice版 - Three steps for faster development that still meets quality and safety goals (zz)
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话题: medical话题: practices话题: device话题: rational
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We recognize the issues for medical device developers. In response, we
created the Rational solution for medical device development (see resources
for links to more information). It provides support for all of the key
activities of development: requirements, modeling, verification, validation
and testing, configuration, and collaboration management. This solution
consists of these elements:
An integrated tool set
Systems engineering and specific medical device practices
Support from experienced field engineers.
The medical device practices concentrate on support for the FDA's Design
Control approach and IEC 62304, as well as material to support Intended Use
Validation of IBM® Rational® DOORS® requirements management
software within your process. The practices provide a basis for developing
content that is specific to an organization. Many people look for "best
practices" in industry areas, but there isn't really a single set of best
practices for medical device development. Essentially, best practice in
engineering consists of delivering what stakeholders want, within the
necessary constraints of time, resources, regulations, and so forth. You
could say that it comes down to the same advice commonly given to presenters
, which we can rephrase as "Say what you are going to do, do it, and then
show that you have done it."
We have identified two common themes as important for medical devices:
Traceability. Not just for requirements, but also including design, design
decisions, verification, validation, tests, and so on.
Documentation. Any regulated industry must be able to produce documentation
that shows what has been done. But many people think the need to produce
comprehensive documentation means using a waterfall-like approach of
creating full documentation for one "stage" before moving on to the next.
The important thing is that enough documentation is produced to justify the
work being done at any point. This supports a wide variety of development
lifecycles, from waterfall to agile approaches.
The IBM Rational solution for medical device development provides access to
context-specific content that you can customize at any point. For example,
while writing requirements in DOORS, engineers can find the recommended
practices to ensure that requirements fit into the company lifecycle,
determine how these practices are implemented in DOORS, and review higher-
level guidance on topics such as traceability. The sections that follow
explain further.
We believe that by adopting the following three steps, you can develop
medical devices rapidly, while staying within regulatory guidelines:
Enhance key process activities to prove compliance
Identify the tool needs for each role
Deploy an integrated toolset
Together, these steps foster innovation by enabling teams to collaborate and
focus on design.
Step 1. Enhance key process activities to prove compliance
Step 2. Identify the tool needs for each role
Step 3. Deploy an integrated toolsetSummary
The three steps that we have discussed here can help accelerate the
development of your products. To produce medical devices that meet changing
healthcare needs and standards, the team that engineers the medical device
systems must collaborate to manage all of the development work products. IBM
Rational software provides an integrated solution for these engineering
teams so they can address the challenges of developing medical device
software. The solution offers a process based on the principles of agile
development and adds modeling the architecture, sophisticated requirements
management and automated reporting capabilities to help medical devices not
only meet various regulatory standards like 21 CFR Part 820 and IEC 62304,
but also reduces the effort of proving this compliance by linking the
development tools.
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问题请教: Design control process学术第一贴 - 美国器械分类.
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相关话题的讨论汇总
话题: medical话题: practices话题: device话题: rational