Medical Device Design Controls - 6 Best Practices Manufacturers Should Follow for FDA Compliance

    Implement proper design controls when designing and developing medical devices to avoid FDA enforcement actions and product recalls.

    Inadequate design controls continue to be highlighted by the FDA as a major reason for warning letters issued to medical device companies. Manufacturers who have lax controls over design and development of devices also have to recall products as they may endanger user safety. Such actions have a negative impact not just on company profit margins, but also reputation and public trust. This article discusses six best practices that medical device manufacturers should follow in order to devise and implement design controls that are compliant, adequate and help in making products that are safe and effective.

    Risk-based Design Control

    The Regulatory Requirements for Design Controls

    Medical device design control was not originally a Good Manufacturing Practice (GMP) requirement. In 1996, preproduction design control requirements were added to the Quality System Regulations and two years later the FDA began enforcement of these rules. Regulatory requirements for design controls are detailed in 21 CFR 820.30.


    Companies that manufacture any kind of class III or class II device have to comply with the requirements listed in 21 CFR 820.30. The following class I devices should also be manufactured under with adequate design controls:

    • Devices automated with computer software
    • Catheter, tracheobronchial suction
    • Surgeon's glove
    • Protective restraint System,
    • Applicator,
    • Radionuclide,
    • Manual Source, radionuclide therapy

    Design controls should be applied during the following:

    • When introducing new products
    • During procedural changes
    • When components are changed, including supplier changes
    • During changes to software
    • When changing manufacturing equipment
    • If a customer-specific order is made

    When Medical Device Design Controls Should Start?

    Manufacturers should start design controls after research and pre-development activities have ended and product development is to begin.

    6 Design Control Best Practices Medical Device Manufacturers Should Follow

    1. Create a Robust and Detailed Design and Development Plan
    2. A detailed design and development plan, which describes the activities and responsibilities required for the design and development of a product, is critical in ensuring the manufacture of safe and effective medical devices.

      A plan should at the very least include the following elements to fulfill regulatory requirements

      • New product proposal
      • Team members with their roles clearly detailed
      • Details of different group involved in design and development
      • The way different groups interface with each other
      • A clear project schedule that describes and references the various design activities from beginning to end.

      The schedule should include:

      • Risk management plan
      • Regulatory assessment
      • Design verification and validation processes
      • Major design reviews
      • Design output approval processes
      • Design transfer approval processes

      The plan should be reviewed each time changes are made to it and these should be approve

    3. Ensure Design Input Includes All Necessary Elements

      Design input is defined in the regulations as the physical and performance requirements of device used as a basis for device design. These should include

      • Physical and performance specifications as well as requirements for functions and interfaces Intended use
      • User and patient needs
      • Safety and reliability requirements
      • Environmental requirements and limitations
      • Requirements for labeling and packaging
      • Any issues related to human factors
      • A proper risk analysis that identifies possible hazards

      Design input requirements should be documented, reviewed and approved by designated personnel. The procedures should have a mechanism for resolving incomplete, ambiguous or conflicting requirements

    4. Carry Out Detailed Design Reviews
    5. The regulations define a design review as a documented and comprehensive systematic examination of a design area, process or procedure to:

      Design reviews are of many types and have to be done at various stages in the design process. A design review should have at least two people involved - the designer presenting the item to be reviewed and an independent reviewer.

      A product level design review may be a global review of a significant stage in product development and has to be included in the initial project plan. Ideally, the product level design review should be carried out at design input approval and at design output approval.

      A focused design review attended by a focused group should do an in-depth evaluation of significant component or sub-assembly. It should be conducted after design input approval but before design output approval.

    6. Verify and Validate Device Design
    7. Design verification and validation processes are regulatory requirements that manufacturers often fail to fulfill in a compliant manner. According to the FDA regulation, verification is meant to confirm by examination and provision of objective evidence that the specified requirements have been met. In order to verify design of a medical device, design output should meet the design input requirements.

      Documentation of design verification is vital - the following should be included in the Design History File:

      • Identification of the design
      • Methods used in verification
      • The date of the verification exercise
      • The individuals involved in the verification process

      The regulation defines validation as establishing through objective evidence that the device specifications conform to user needs and intended use. In order to carry out validation properly, the operating conditions have to be defined and initial production units or lots have to be used. This process, like verification, must be documented in the Design History File:

      • Results of the validation process
      • Identification of the device
      • Validation methods used
      • Date of validation
      • Details of individuals carrying out the validation

    8. Do Design Transfer Correctly
    9. Getting the design transfer wrong - that is, translating design into production specifications - can affect a product's performance, safety and effectiveness. In order to ensure this does not happen and design transfer is done correctly, companies:

      • Must change status of documents generated during the design process to production
      • Detailed manufacturing procedures have to be developed
      • Proper test and inspections procedures have to be formulated and implemented
      • Personnel should be trained well
      • Equipment should be correctly installed and serviced properly Should carry out product level design review

    10. Maintain Complete Design History Files
    11. A Design History File or DHF is a compilation of records which describes the design history of the finished device. It should be clearly identified and have a table of contents. The DHF must include:

      • Product specifications
      • List of all project team members involved and their roles in the design process
      • The various groups involved and the way they interface with each other
      • Risk management plan
      • Project plan
      • Design review meeting during the design input approval phase (include details such as meeting minutes)
      • Design input approval documentation
      • Completed in-process design changes form
      • All necessary design verification and validation test protocols
      • All design reviews documentation in chronological order
      • Applicable clinical evaluation data such as trial sites, protocols, results and so on

      Compliant Design Controls - A Must for Safe and Effective Medical Devices

      As explained earlier in this article, proper, compliant design controls are necessary not just for regulatory compliance, but also to ensure that products manufactured are safe and effective. The fact that inadequate design controls continue to be the third most cited cause for FDA violations is a clear indication that device companies are not taking the need for them more seriously. As has been shown, weak design controls can lead to warning letters, product recalls, plummeting profits and decrease public trust in a company. Design controls, therefore, should not be an afterthought in the design and development process of a device - rather, they have to be an integral part of it.

      How can medical device compliance training help?

      The areas highlighted above are just a small part of the wide range of practices and processes for medical device compliance. Subjects such as device compliance are multi-faceted and complex and can be better understood after attending a training course such as the ones offered by ComplianceOnline. Our courses are available as live webinars, training recordings seminars. We also offer customized training courses developed in conjunction with organizations that wish to train large groups of their employees.

      If you need customized training courses or specialist medical device compliance consulting services, please contact us through email [email protected] or call us
      at this toll-free number: +1-888-717-2436.