Get your QMS up and running without starting from scratch.
Regulix QMS is a library of ready to use, professionally written QMS templates designed for medical device startups. Built to meet ISO 13485, FDA QMSR/21 CFR Part 820, and ISO 9001 requirements, our templates give you everything you need to establish a compliant quality management system quickly and confidently. One time purchase, no subscription required.
Sound familiar?
"We need a QMS but don't have time to write everything from scratch."
Our templates are professionally written and ready to customize. Skip the blank page and get to implementation faster.
"We're not sure if our documents meet ISO 13485 or FDA requirements."
Every template is built to meet ISO 13485, FDA QMSR/21 CFR Part 820, and ISO 9001 so you can be confident your documents are compliant before the auditor walks in.
"We can't afford a full consulting engagement or additional resources right now."
Regulix QMS is a one-time purchase that gives you a professional foundation at a fraction of the cost of a full consulting engagement.
"We have an audit coming up and need to fill gaps fast."
Our templates cover the most common audit gaps including risk management, CAPA, internal audits, and SOPs so you can close gaps quickly and confidently.
What you get.
Every template is professionally written, fully editable, and ready to customize to your company. Built to meet ISO 13485, FDA 21 CFR Part 820, and ISO 9001.
SOPs
Standard operating procedures covering core quality system processes required for ISO 13485 and FDA compliance.
Risk Management Templates
ISO 14971 aligned risk management templates including risk assessment, risk register, and benefit risk analysis.
Forms
Ready to use forms to support your SOPs and document control requirements.
CAPA Templates
Corrective and preventive action templates to help you identify, investigate, and resolve quality issues in a structured and compliant way.
Policies
Quality policy and supporting policy documents aligned to ISO 13485 and FDA requirements.
Audit Checklists
Internal audit checklists mapped to ISO 13485 and FDA QMSR/21 CFR Part 820 requirements to keep your audits structured and thorough.
Built to meet the standards that matter.
ISO 13485
The international standard for medical device quality management systems. Required for most global market registrations.
FDA QMSR/21 CFR Part 820
The FDA Quality System Regulation governing medical device manufacturers selling in the US market.
ISO 9001
The general quality management standard applicable across industries and often required by customers and suppliers.
Ready to get your QMS in order?
Complete the form and we will be in touch within one business day with details on how to purchase and access your templates.