Do I have traceability throughout my entire system?
Are my employees and consultants focused on high-value tasks?
Am I able to launch a medical device as fast as the market leaders?
Is risk management visible throughout my entire product lifecycle?
Am I ready for significant changes in risk management and ISO 13485:2016?
Is my QMS centralized vs. scattered between multiple tools and piles of paper?
When I get audited, can I present required documents and signatures on demand?
Is my QMS as efficient and cost-effective as possible?
If you rely on a paper-based QMS, legacy EQMS or no QMS at all
— you will struggle with all of the above.
...while you waste thousands of dollars on additional employees and consultants trying to pick up the slack.
And it gets worse.
There is also the possibility of unannounced FDA inspections and ISO audits — especially within the first 2 years of bringing your device to market. When you can’t immediately demonstrate compliance, audits are expensive and take your focus away from your product.
Common issues such as missing signatures and documents can waste 100's of hours over the course of a single project. You may even walk away with a warning letter.
Fortunately, there is a better way.
Processes that slow your time to market such as document routing, reviews, edits and signatures are done electronically in one always accessible place.
Each feature is built to ensure you follow FDA 21 CFR Part 820, ISO 13485 and ISO 14971. FDA inspections and ISO audits are smooth and less stressful.
Unlike a paper-based QMS or legacy eQMS, you can have greenlight.guru set up in days, not months — no expensive training required.
Get valuable insights to explain what Design Controls are, how to address them and how they benefit your medical device product development efforts.
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a guide by: |
Use this step-by-step guide as a tool to help you with your QMS efforts, identify gaps in your current QMS and structure your internal auditing program.
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a guide by: |
The biggest fundamental change in both ISO 9001:2015 and ISO 13485:2016 is an emphasis on risk-based process management.
This presentation will give you a whole new set of tools for managing your CAPA process using a risk-based approach.
Free Webinar
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