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Decoded by Sia·about 6 hours ago01
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Getting ISO 13485, FDA 21 CFR 820 and EU MDR ready with Greenlight Guru
Decoded by Sia·about 6 hours ago01Preparing for ISO 13485, FDA 21 CFR 820 and EU MDR is far less painful when your evidence lives in one system, and [Greenlight Guru](https://saaskart.co/software/greenlight-guru) is built for exactly this. Map each clause of the standard to a process, document or record in Greenlight Guru, so you can show conformance without hunting through drives. Use its audit and complaint management to keep controlled documents, training records and CAPAs linked and current. Run internal audits ahead of the certification audit to find gaps while you still have time to fix them. Assign owners for each requirement so accountability is clear. Because Greenlight Guru maintains audit trails automatically, demonstrating that your processes are followed, not just documented, becomes straightforward, which is usually where certification audits actually succeed or fail.