If you are developing a medical device, you will need to become familiar with Design Controls. 21 CFR 820.30 states that every class III and class II medical device manufacturer “shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met”.1 Design controls are an essential part of any medical device’s quality system since they link user needs, design inputs, design outputs, design verification, and design validation to show proof of safety and effectiveness.
Risk management (ISO 14971) goes hand in hand with the design controls process. The intent behind both risk management and design controls are to identify and mitigate any potential product issues.2 The two practices should feed into each other; as you identify hazards associated with your device you can translate them into design controls and use design outputs, verification, and validation as risk controls. It is important to note however that they are not substitutes for each other. An effective quality system implements and utilizes both practices to maximize the safety and effectiveness of the device.
A design history file, or DHF, is where all your design control documents are maintained and organized. Your DHF is what every FDA inspector or auditor will want to see when they drop in for an inspection. 21 CFR Part 820.30 states that “The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan…” Any design and development planning documents, any design input/output trace matrices, verification, validation, and design changes should be documented as part of the DHF. The DHF should be a robust and complete, stand-alone document that tells the story of your medical device through design controls.
Since device development and design controls can be a lengthy process, it is required by regulating bodies to have meetings to assess certain aspects of the process, these are called design reviews. There is no formal requirement for how many design reviews you must conduct during the process, so it is completely up to the project team to determine how many are necessary based off the complexity of the project3. For example, design reviews can happen after user needs and design inputs are determined, then again prior to initiating any verification and validation activities, and again when the device is ready for design transfer. Design reviews are intended to assess the different steps in the design control process and allow you to both recap the work that has already been done, and plan for the work still needed.
If you need help developing your medical device, EMMA International can work with your team through the design controls process. Contact us at 248-987-4497 or email email@example.com to see how we can help!
1FDA (April 2019) CFR – Code of Federal Regulations Title 21 retrieved on 11/20/2019 from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.30
2BSI (January 2019) ISO 14971 Risk Management retrieved on 11/20/2019 from: https://www.bsigroup.com/en-US/medical-devices/Our-services/ISO-14971-Risk-Management/
3Tartal (n.d.) Design Controls retrieved on 11/20/2019 from: https://www.fda.gov/media/116762/download