Quality Plans
Quality plans are a comprehensive approach to documenting activities that ensure the safety and effectiveness of a medical device. We will write a quality plan covering any gaps you may have in your quality system prior to or as a result of audit activities. Basic Quality Plans cost $4,850 with a turnaround time of 4 weeks (or less, kinda cool!!). Comprehensive Quality Plans cost $9,975.
Basic Quality Plan - For Class I or simple Class II device. Covers basic SOPs, document control, supplier quality, etc.
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Comprehensive Quality Plan - For Class II or III devices. Includes full QMS buildout, design controls, risk management, etc.
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Remediation Plans - For companies addressing gaps post-audit or warning letter. These are a bit more complicated. (Lets chat about that before we give you a price)
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Email us with any questions: quality@novomedtek.com
What we need from you
We need a brief summary of your problem and how you want to approach solving it.. We can even help you problem solve if you are too overwhelmed. We will call or email you to discuss the details and hammer out a timeline that works.
How to use them
Think of a Quality Plan like your “get out of jail free” card. If you find a gap during an internal audit—or right before an FDA, EU, or other regulatory visit—a Quality Plan shows the auditor that you’re on top of it. You know there’s an issue, and while you haven’t had time to fully fix it yet, you’ve got a solid, documented plan in motion. It’s your way of saying, “Yep, we see it, we’re handling it,” so you don’t get caught off guard when the suits show up.
How does it work
It sounds too good to be true but it's not. Quality Plans are a legal, compliant, tool for companies to outline future work from a quality or regulatory perspective to address deficiencies discovered during internal audits, periodic reviews, or middle of the night panic attacks. Ask your auditor, they will confirm it!!