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Research and development of a medical device often takes years of preliminary feasibility studies and false starts before an official project team is formed. It can be confusing to know when to start design controls.

The FDA did not intend design controls to apply to ideation or feasibility studies when the requirements were introduced into the Quality System Regulation (QSR) in 1996. Instead, design controls should begin once it is decided that a design will be developed. Below are five key indicators for when design controls should commence:

        • Project charter approvalstart button
        • Obtaining product development funding
        • Formation of a product development team
        • Completion of product feasibility studies
        • Initial generation of design inputs

 

Some medical device developers may want to substitute testing performed during preliminary research for verification or validation of design requirements so that additional testing is not needed in later stages. However, use of preliminary data is not an accepted practice because it generally lacks traceability and is not representative of the final device.

Design controls require:

        • Testing to a pre-approved protocol with acceptance criteria
        • Approval of protocol deviations and/ or additions
        • Use of validated test methods and qualified test equipment
        • Test samples to be equivalent to final design
        • A statistically valid sample size

 

The purpose of design controls is to assure that only safe and effective medical devices reach the market. Medical device developers should keep this in mind when determining when to initiate design controls. For information on avoiding common mistakes in design controls, refer to QA Consulting’s first Design Control Series article here.

Read more about the medical device design transfer process.

If you need assistance implementing or managing design controls, please call 512-328-9404 or contact us at info@qaconsultinginc.com.