There is a very strong correlation and relationship between Design Controls and Risk Management.
Design Controls are intended to demonstrate that a medical device has been:
- Designed to address the needs of users and patients.
- Designed to meet inputs and requirements.
- Proven to meet applicable standards.
- Meets performance criteria.
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Your Design Controls will prove that your medical device is safe for use.
Risk Management identifies, evaluates, analyzes, assesses, and mitigates potential product issues.
Design Controls and Risk Management address design, development, and manufacturing of medical devices from slightly different perspectives. Essentially, they are two sides of the same coin.
Reduce Product Risks With Good Design Controls
Realize Design Controls and Risk Management are related.
Realize that your overall goal in medical device product development and manufacturing is to prove and demonstrate that your product meets clinical needs, design inputs and requirements, and is safe and effective.
If you are thorough with defining and documenting User Needs, Design Inputs, Design Outputs, Design Verification, Design Validation, and Design Reviews, then you will be on the right track towards ensuring your medical device is safe.
Prior to clinical use, you have to know without a doubt that the product is safe and/or determine that the medical benefits outweigh the risks (which should be documented in a risk / benefit analysis).
Embrace this in your own medical device product development efforts.
Effectively Combining Risk Management and Design Controls
The best practices of medical device product development have a good flow between Design Controls and Risk Management.
For example, as you identify hazards and hazardous situations, these should “feed” into the Design Controls process in defining User Needs and Design Inputs.
When you evaluate risks, you will need to establish Risk Controls to mitigate and reduce risks. Design Outputs, Design Verifications, and Design Validations become these risk controls.
In fact, using Risk Management as a real tool will help you with Design Verification and Design Validation planning. Risk Controls are used to help identify ways to reduce the risks. Your Risk Controls should align with and include Design Verification and Design Validation activities.
The more fully you integrate Risk Management and Design Controls, the safer and more useful your medical device will be.
To learn more about about the complete Risk Management process as it directly relates to ISO 14971, check out the infographic below.
