Regulatory Open Forum

Hi All,

Is there any guidance document to better understand the medical device user requirements down to product requirements and then into sub-system requirements and then finally to verification and validation to make a successful product launch in the market.

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Jayaram Abimanyu
Chennai
India
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Hello Jayaram

Yes, there are many.  You might begin with the US FDA Design Control Guidance.  https://www.fda.gov/media/116573/download


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Anne LeBlanc
United States
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Original Message:
Sent: 22-Oct-2021 02:17
From: Jayaram Abimanyu
Subject: Guidance document if any for medical device requirements

Hi All,

Is there any guidance document to better understand the medical device user requirements down to product requirements and then into sub-system requirements and then finally to verification and validation to make a successful product launch in the market.

------------------------------
Jayaram Abimanyu
Chennai
India
------------------------------

Hello Jayaram,

As Anne said, there are many including IEC 62366, IEC 62340 (if software), FDA guidance, MHRA guidance, etc.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 23-Oct-2021 01:37
From: Anne LeBlanc
Subject: Guidance document if any for medical device requirements

Hello Jayaram

Yes, there are many.  You might begin with the US FDA Design Control Guidance.  https://www.fda.gov/media/116573/download


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Anne LeBlanc
United States

Original Message:
Sent: 22-Oct-2021 02:17
From: Jayaram Abimanyu
Subject: Guidance document if any for medical device requirements

Hi All,

Is there any guidance document to better understand the medical device user requirements down to product requirements and then into sub-system requirements and then finally to verification and validation to make a successful product launch in the market.

------------------------------
Jayaram Abimanyu
Chennai
India
------------------------------

There are many. I think all countries have different ones.)

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Oksana Kolosova
Moscow
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Original Message:
Sent: 22-Oct-2021 02:17
From: Jayaram Abimanyu
Subject: Guidance document if any for medical device requirements

Hi All,

Is there any guidance document to better understand the medical device user requirements down to product requirements and then into sub-system requirements and then finally to verification and validation to make a successful product launch in the market.

------------------------------
Jayaram Abimanyu
Chennai
India
------------------------------

Try reading FDA's Design Control Guidance For Medical Device Manufacturers, Guidance for Industry, MARCH 1997.  It covers inputs, outputs, verifications, and validations.

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William Coulston PMP, MS, RAC
Director of Quality & Regulatory Affairs
San Antonio TX
United States
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Original Message:
Sent: 22-Oct-2021 02:17
From: Jayaram Abimanyu
Subject: Guidance document if any for medical device requirements

Hi All,

Is there any guidance document to better understand the medical device user requirements down to product requirements and then into sub-system requirements and then finally to verification and validation to make a successful product launch in the market.

------------------------------
Jayaram Abimanyu
Chennai
India
------------------------------