The FDA released the June 2023 version of the Guidance on “Content of Premarket Submissions for Device Software Functions,” and it is a major revision, impacting significantly your Quality Management System (QMS). Proper execution of these changes requires a methodological process. Here we provide some of the overview about how you can easily integrate guidance and making sure that integration remain compliant and your processes become smooth.
Step 1: Brush up on the New FDA Guidance
Before you do anything, read the new FDA guidance with a fine-toothed comb, focusing on those changes and recommendations that are hard for your QMS. Discover which areas you need to change in your current processes, procedures and documentation.
Step 2: Evaluate the Gap between Current and Revised QMS.
Do a gap analysis to know what is different in your current QMS with the requirements as specified in updated guidance. Excogitate how these changes will affect your processes, procedures, documentation and resources. That analysis would be the foundation of your implementation plan.
Step 3: Plan for Implementation:
Draft a full implementation plan that details the steps to executing — what, by whom, by when this is built into your QMS.
Using In-Person Presence: Deliver clear communication and set up your workspace so that you can interface with the rest of your stakeholders.
Step 4: Amend QMS Procedures and Documentation:
Once you have updated your documentation guidance you will need to review related QMS procedures, policies and hardcopy for any amendments. Revise and update these documents to include the new criteria. Implement change procedures for all relevant risk management, cybersecurity, clinical evaluation, human factors engineering, validation and verification etc.
Step 5: Training & Education
Train and educate your team members on the new FDA guidance and how it affects what is being developed in your QMS. Offering training sessions so that employees know where they stand, what their roles and responsibilities will be under the new system. Respond to any questions or concerns and double down on the need for compliance
Step 6: Review & Validate Changes:
Perform comprehensive reviews and validation on updated QMS processes, procedures, and documentation. Make sure they are consistent with FDA guidance and can accomplish the required objectives. Involve the internal and external stakeholders like QA teams, regulatory experts, auditors to ensure these are validated.
Step 7 — Implement and Monitor Rolling out:
Monitoring the revised QMS processes, procedure, documents throughout your organization. Continue to monitor closely during implementation, collect feedback from end users and troubleshoot any challenges that come up. Ongoing monitoring and review of the results is necessary to go back in case of improper changes.
Step 8: Record Any FDA Guidance Based Changes Made to Your QMS Document:
Record any changes you have made to your QMS as a result of this reproducing the section by section. Make updates to your QMS documentation (policies, procedures, work instructions and forms) so these changes are correctly articulated within the associated documents. Inform the interested parties about the updated QMS and ensure that everyone has access to a copy of the current version.
Step 9: Continual Improvement:
Keeping the spirit of continual improvement alive means re-evaluating your QMS on a regular basis and looking for additional areas for improvement. Monitor official announcements from the FDA or new industry standards (as applicable) to keep your QMS in compliance and on the cutting edge.
Incorporating Changes of FDA Guidance into to Your Quality Management System:
This needs to be done if you want to stay in compliance as well as ensure safety and effectiveness of your device software functions.; This step-by-step guide will help you to integrate the new requirements with your existing information security processes and a way in which it fits your organization as quickly as possible. Dear colleagues, take these changes as an opportunity with which to improve your QMS and lead the way into improving the care of patients.
It is worth mentioning though that a system like this requires planning, collaboration and continuous oversight to be effective. Navigate the implementation process with a proactive and adaptable strategy, using the new FDA guidance to easily and efficiently strengthen your QMS.
Contact us if you have any questions on how to meet the new 2023 FDA Guidance Content of Premarket Submissions for Device Software Functions requirements. We are here to help you.
Reach out to us at BioBoston Consulting or on our website if you would like support for your organization.