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Built for MedTech and Life Science SMEs who need ISO/FDA compliance without extra SaaS.
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Microsoft 365 First – No extra SaaS, no new licenses.
Right-Sized – Compliance built for SMEs
Proven – ISO 13485, MDR, FDA 21 CFR Part 11 support.
Microsoft 365 First – No extra SaaS
Right-Sized – Compliance built for SMEs
Proven – ISO 13485, MDR, FDA
FAQs
Is QMSure a SaaS?
No. QMSure is a consulting and implementation service. We configure the Microsoft 365 tools you already own (SharePoint, Power Automate, Teams) into a compliant QMS without adding another platform.
Does it meet ISO 13485, MDR, and FDA 21 CFR Part 11?
Yes. QMSure is designed around these standards, covering document control, CAPA, training records, audit trails, and electronic signatures.
How quickly can we be audit-ready?
Most SMEs cut prep from months to weeks. We focus on fast wins while building a solid QMS foundation.
Is QMSure a SaaS?
No. QMSure is a consulting and implementation service. We configure the Microsoft 365 tools you already own (SharePoint, Power Automate, Teams) into a compliant QMS without adding another platform.
Does it meet ISO 13485, MDR, and FDA 21 CFR Part 11?
Yes. QMSure is designed around these standards, covering document control, CAPA, training records, audit trails, and electronic signatures.
How quickly can we be audit-ready?
Most SMEs cut prep from months to weeks. We focus on fast wins while building a solid QMS foundation.
Is QMSure a SaaS?
No. QMSure is a consulting and implementation service. We configure the Microsoft 365 tools you already own (SharePoint, Power Automate, Teams) into a compliant QMS without adding another platform.
Does it meet ISO 13485, MDR, and FDA 21 CFR Part 11?
Yes. QMSure is designed around these standards, covering document control, CAPA, training records, audit trails, and electronic signatures.
How quickly can we be audit-ready?
Most SMEs cut prep from months to weeks. We focus on fast wins while building a solid QMS foundation.