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MedicalDevice版 - 问题请教: Design control process
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进入MedicalDevice版参与讨论
1 (共1页)
b***p
发帖数: 1398
1
应该从哪些方面回答?
衙内给讲讲。
s**********8
发帖数: 25265
2
啥问题?

【在 b***p 的大作中提到】
: 应该从哪些方面回答?
: 衙内给讲讲。

b***p
发帖数: 1398
3
for example, 面世时候,问你对这个的理解,怎么回答。
s**********8
发帖数: 25265
4
CFR 820 subpart C.
for quality, safety and design under defined criteria.

【在 b***p 的大作中提到】
: for example, 面世时候,问你对这个的理解,怎么回答。
b***p
发帖数: 1398
5
1. first, it's very important (part of QSR). it will save lead time/cost,
2. lifelong process associated with the product;
3. make and follow a thorough plan for all phases (everything reviewed &
documented)
4. team work
5. risk analysis
知识点够不够?
s**********8
发帖数: 25265
6
不够.
know this term: design planning, design input, design output, design review,
design verification, design validation, design transfer, design change,
design history file, design master record.

【在 b***p 的大作中提到】
: 1. first, it's very important (part of QSR). it will save lead time/cost,
: 2. lifelong process associated with the product;
: 3. make and follow a thorough plan for all phases (everything reviewed &
: documented)
: 4. team work
: 5. risk analysis
: 知识点够不够?

s**********8
发帖数: 25265
7
device master record i mean

review,

【在 s**********8 的大作中提到】
: 不够.
: know this term: design planning, design input, design output, design review,
: design verification, design validation, design transfer, design change,
: design history file, design master record.

1 (共1页)
进入MedicalDevice版参与讨论
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话题: design话题: process话题: control话题: 问题话题: qsr