Manufacturing Process Control Toolkit: FDA 820.70 + ISO 13485 Templates
Manufacturing Process Control Toolkit — process control procedure, batch record (DHR), in-process inspection checksheets, SPC control charts, equipment qualification, and environment monitoring.
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FDA Inspection Readiness Checklist
27-point checklist based on real 483 observations
Quarterly Regulatory Updates
Free updates when FDA guidance changes
Implementation Quick-Start Guide
Step-by-step instructions to deploy templates in your QMS
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Frequently Asked Questions
What is a Device History Record (DHR)?
The DHR is the collection of records containing the production history of a finished device. FDA 21 CFR 820.184 requires DHR procedures and records including manufacture date, quantity, acceptance records, labels, and device identification.
Is SPC required for medical device manufacturing?
Not explicitly required, but ISO 13485 Section 8.4 requires analysis of process performance data. SPC is widely expected as evidence of a controlled manufacturing process during audits.
What file format are the templates in?
All templates are provided in editable Microsoft Word (.docx) format. You can customize them to match your company's branding and specific requirements.
How quickly will I receive the files?
Instantly. After purchase, you'll receive an email with download links within 2-3 minutes. Check your spam folder if you don't see it.
Can I use these for multiple projects or clients?
Yes. Your purchase includes a company-wide license. Use the templates across all your projects and devices within your organization.
Do these templates get updated when regulations change?
Yes. You'll receive free updates via email whenever we update templates for new guidance or regulatory changes.
What if I need help customizing the templates?
Email us at support@regwatchdaily.com. We typically respond within 24 hours with guidance on customization.
Is there a money-back guarantee?
Yes — the Audit-Ready Guarantee. If you're not satisfied within 7 days, email us for a full refund. No questions asked.
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7-Day Iron-Clad Guarantee
Download everything. Review every template. If it doesn't save you at least 40 hours of documentation work, email us for a full refund. No questions. No hassle.
Every week without proper documentation is another week of audit exposure.