Why do you need to manage requirements for a medical device?

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Why do you need to manage
requirements for a
medical device?

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MDD (Europe) & FDA (US) both
require medical device
companies to develop
according to some quality
standards

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Standards:
• ISO13485 – Medical Devices Quality Management
• IEC60601-1 – Medical Devices Electrical Safety
• ISO14971 – Medical Devices Risk Management
• IEC62304 – Medical Devices Software
• IEC62366 – Medical Devices Usability
• …

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What needs to be done?
Planning of processes Execution of processesRelevant standards

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How is it verified?
1. Review of the static documentation at
certification (CE Mark or 510(k))
2. Review of the dynamic documentation during
audits (scheduled or unannounced)

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Certification
These documents build a file: Design History File (FDA) or Technical File (CE)
• It contains some plans and
• lots of documents which describe the product
Planning of processes Execution of processesRelevant standards
plans design documentation

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Audits
During the audit there is also a strong focus on reviewing the process
documentation which should prove that you followed your own processes.
Planning of processes Execution of processesRelevant standards
plans design documentation
process documentation

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Standards do not necessarily
tell you
• How to do things
but
• What needs to be done
• What evidence needs to be shown

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User Requirements
• User Requirements (or Marketing Requirements)
make sure you make something which addresses
the users needs

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System Requirements
• System Requirements make sure your engineering
team knows what to build

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Requirements Specifications
• Requirements specifications (aka Design Output)
make sure you know what has been built

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Risks and Risk Controls
Risks and Risk Controls make sure you build a safe
device

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Usability
Frequently used functions, worst case use scenarios,
critical user interface functions make sure the
product is easy to use and is not prone to user errors

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Validation
Validation is the assurance that the product meets
the needs of the customer

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Verification
Verification is the assurance that the product does
what it was designed to do

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How many?
Example of a simple class B device (medium risk)
Usability
• 30 frequently used functions
• 5 critical user interface functions
Risks
• 127 risks
• An average of 2.7 risk control/risk
User Requirements
• 47 User/Marketing Requirements
System Requirements
• 384 System Requirements
Requirement Specifications
• 841 Software & Hardware Requirements
Verification
• 512 Test cases
• Average of 35 test steps / test case
Validation
• 40 Validation Tests
• Average of 15 test steps / test case

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Traceability
You are required to maintain a traceability file to
show that:
• Each risk control is tested
• Each user requirement is implemented
• etc …

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Traceability
Usability
User Requirements
System Requirements
Requirement Specification
Verification
Validation
Risks and Risk Controls

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Looks like a lot of work?
If you start early with documentation:
• you will be faster in the end
• you will have a better product
• you will have a safer product

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Using the right tools will:
• Not add much overhead
• Make sure everybody in the company is involved
and understand why he is doing something
• Allow you to see what are the impacts of a
proposed change
• Allow your team to work agile and still produce
the required documentation