Here are two powerful tools that can make interactive communications with FDA more efficient if your device is eligible.

A Management Review is a regulatory requirement mandating that top leadership conduct a periodic, documented evaluation of the entire Quality Management System (QMS). Its purpose is simple: ensure the system is functioning effectively and continuously improving.
Despite its importance, companies are frequently written up during audits for issues related to this required review. In her video, Linda Bradon, owner of Secure BioMed Evaluations, breaks down the three most common reasons organizations receive findings — and how your team can stay ahead of them.

1. Your Procedure Doesn’t Align With the Regulations

One of the fastest ways to get written up is having a written procedure that doesn’t match what the regulations require.

This often happens when companies:

• Use outdated templates
• Copy procedures from another organization
• Modify processes without updating documentation

If your procedure doesn’t reflect current regulatory expectations, auditors will catch it — even if your intentions were good.
Tip: Schedule yearly internal reviews to ensure your QMS procedures are aligned with the most current regulatory standards.

2. You Add Extra Requirements… and Then Forget to Do Them

Many companies create Management Review procedures that include additional requirements not found in the regulations.

This becomes a problem when:

• Those internal requirements aren’t completed consistently
• Teams don’t remember they were added
• No system is in place to track them

Anything written in your procedure becomes your obligation — whether or not it’s required by regulation. Failing to meet your own requirements is still a finding.
Tip: Keep procedures clean and concise. Only include steps that are truly necessary and fully sustainable.

3. Your Management Review Record Is Incomplete or Inappropriate

Even if the review is conducted, another issue often triggers a write-up:

The record doesn’t meet regulatory requirements.

This could be due to:

• Missing agenda items
• Incomplete data
• Lack of signatures
• Poor documentation structure

A Management Review isn’t complete until the record is accurate, compliant, and audit-ready.
Tip: Use a standardized template and assign a compliance owner to verify the record before finalizing it.

Is Your Company Struggling With Management Review Compliance?

If creating compliant procedures, executing requirements, or documenting Management Reviews feels overwhelming, you’re not alone. Many organizations face the same challenges — and that’s exactly where Secure BioMed Evaluations can help.

Whether you need a full QMS audit, a Management Review overhaul, or support with proper documentation, reach out to Linda Bradon and her team for expert guidance.