ISO 13485:2016 Medical Device -QMS|Clause 7.3 Design and Development |L-9| Research and Development

Подробнее о видео

ISO 13485:2016 Medical Device -QMS|Clause 7.3 Design and Development |L-9| Research and Development@ivdmanufacturing7208

The organization is required to document all processes for design and development. The organization is required to control all design and development processes for their products, and with the design and development all steps must be well documented. The organization must also maintain a design and development file for each medical device type or medical device family.

The design and development for ISO 13485 should be a continuation of customer needs and requirements.

Could you enter into design and development without documented customer needs and requirements? Theoretically, yes, you can. Is it a good idea? In my expert opinion: Doing so would be a terrible idea and incur significant business risks that can be largely avoided. I stress this because:

Way too many design and development teams dive into product development without a clear understanding what is important about the eventual product from the perspective of the customers.
Why are you developing medical devices to begin with? I assume it is for customers (patients). I assume it is to improve quality of life.
Not having clarity on customer needs will more than likely result in costly reworks, revisions, and loss of time.
Do yourself a huge favor and define customer needs and requirements as comprehensively as possible.

With that said, let me offer one quick note. You do not need to have a complete list of customer needs to be documented before diving into design and development. It is perfectly acceptable to apply agile methodologies and be iterative. Just try to have enough clarity about what issue you are trying to solve before diving too deep into development.

Design and development processes include:

Design and Development Planning
Design and Development Inputs
Design and Development Outputs
Design and Development Reviews
Design and Development Verification
Design and Development Validation
Design and Development Transfer
Control of Design and Development Changes
Design and Development Files

List of Queries
What is ISO13485:2016|ISO13485:2016 in Hindi | Medical Device Manufacturer| ISO13485:2016 kya hai ??
What are the requirements of ISO 13485 for medical devices
6 Steps to ISO13485:2016 and MDSAP Certification
Clauses of ISO13485:2016 in Hindi
iso 13485 medical devices
iso 13485 medical devices in hindi
iso 13485 interview questions
iso 13485 training
iso 13485 lead auditor training
iso 13485 clauses explained
iso 13485 certification
iso 13485 explained
iso 13485 audit
iso 13485 internal auditor training
iso 13485 medical devices in telugu
iso 13485 medical devices in tamil
iso 13485 standards
medical device manufacturers
in vitro diagnostics


✨ Subscribe and hit the bell icon to see the latest videos....

Follow Amar on your favorite Social Media Channels:

👉🏻 Facebook:

👉🏻 Instagram:

👉🏻

👉🏻 YouTube:

👉🏻 Whats App :

LETS LEARN TOGETHER AND GROW TOGETHER !!