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.
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.
Trust the only cloud-based eQMS made for medical device companies to provide a single source of truth for your team, processes, documents and records.
Prove to regulatory bodies that you have met design requirements with hassle-free design control documentation, complete traceability and on-demand DHFs.
Comply with ISO 14971 and other industry standards by making risk management an important part of your entire product lifecycle.
Get organized and be audit-ready by managing your controlled documents, records and SOPs in one convenient place.
Get valuable insights to explain what Design Controls are, how to address them and how they benefit your medical device product development efforts.
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.
a guide by:
Understanding what can you do to better manage your team’s 510(k) expectations
Tuesday, August 23rd at 1pm ET / 10am PT
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