This Quality Manual is in compliance with ISO 13485:2016, EU MDR 2017/745, and FDA QMSR 21 CFR 820. Provided in editable Word format, it can be tailored to align with your quality management system and medical device requirements. This is a digital product delivered via email: once purchase is completed, the procedure will be sent to your email within 24 business hours (excluding Sundays, Saturdays, and holidays).
This Quality Manual is designed to support medical device manufacturers in meeting international regulatory requirements. Delivered in editable Word format, it allows easy customization to fit your organization’s quality management system. Additional support is available for upgrading or adjusting procedures, and consultancy services can be arranged flexibly on an hourly fee basis. For clients requiring full implementation or signed, approved procedures, these services are offered at an extra fee- please contact us directly for further information.
Our team is available by email to provide guidance and ensure smooth compliance. Consultancy services can also be arranged via Zoom or, when necessary, on‑site visits. Full implementation or signed, approved procedures are available at an extra fee - please contact us for details.