MEDICAL DEVICE DESIGN IS A HIGHLY REGULATED AND CONTROLLED PROCESS UNDER THE GUIDELINES OF ISO 13485 AND THE 21 CFR PART 820, AND MEDICAL DEVICE COMPANIES MUST FOLLOW STRICT CRITERIA FOR ESTABLISHING DESIGN CONTROLS AND RISK MANAGEMENT TO ENSURE THEIR DEVICES WILL BE SAFE AND EFFECTIVE.

Once you've come up with an idea for a medical device, the next step is to create a medical device design that is safe and effective for the end user. Medical device companies must also establish design controls - a set of policies and procedures for documenting the steps in the design process and ensuring that the medical device you design fulfills its intended purpose and is both safe and effective for the end user.

The key to an effective medical device design process is remembering that the device itself is not the only intended output of the medical device design process. You are also expected to produce a user manual for the device, clearly documented specifications that explain how the device is constructed and how it works, a detailed risk analysis that quantifies the risks associated with your device, technical files, and the results of any testing or studies that you conduct (product validation, bio-compatibility, clinical risk assessment, etc.).

USER NEEDS - THE STARTING POINT FOR MEDICAL DEVICE DESIGN

User needs are the first thing that you need to establish and document if you're about to start designing a medical device. Documented user needs capture the things that are most important about your medical device from the perspective of the doctors, nurses, and especially the patients that will be using the device. The best way to discover user needs is by talking to the people who will use your device and asking questions like:

  1. Who will use the device?
  2. How will medical device users and patients interact with the product?
  3. Where will the product be used? At home? At a hospital? At a clinic?
  4. What is the sophistication level of the person using the device? Will they have some medical training? None?
  5. What other products will be used with the device?

DOCUMENT CONTROLS - WHAT'S REQUIRED?

Design controls is one of the core processes of the quality management system (QMS) described in both 21 CFR Part 820 and ISO 13485. The requirements for design controls are so extensive that we've taken the time to write the most comprehensive guide available on the FDA's design control regulations - you can read all about it here.

If you're short on time, we've outlined the basic steps to an effective design control process below:

  1. You'll have to determine your device classification and whether your device will be subject to design controls. Class II and III devices all require design controls, and Class I devices are mostly exempt with some exceptions.
  2. Create and document a design plan
  3. Establish and document design inputs
  4. Establish and document design outputs
  5. Establish and document a design verification process
  6. Establish and document a design review process
  7. Establish and document a design validation process
  8. Establish and document a process for translating your designs into a manufacturing process
  9. Establish a process for implementing design changes
  10. Prepare a design history file that shows your device was developed in accordance with the design plan and in compliance with the design controls regulations.

STREAMLINE YOUR MEDICAL DEVICE DESIGN WITH GREENLIGHT GURU

For companies who begin medical device design without paying appropriate attention to the design controls process and other medical device regulations, establishing proper documentation and getting their device to market quickly becomes and impossible uphill battle. Greenlight Guru's eQMS is the quality management tool that medical device companies need to help ensure that design controls are established, followed and stored in compliance with FDA and ISO regulations.

Medical device companies that wish to sell their products in the United States will have their quality systems audited by the FDA. Greenlight Guru makes it easy to store, access and share all of your design control documentation, proving your compliance with local regulations and helping you get to market even faster.

Are you interested in learning more about our Quality Management Software? Let’s take Greenlight Guru on a demo.

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