Change Control &
Design Change Toolkit
6 ready-to-use, audit-tested templates that bring your medical device change control process into full regulatory compliance — in hours, not weeks.
Instant digital download · One-time payment · No subscription
Is Your Change Control Process a Ticking Time Bomb?
Everything You Need — 6 Documents
Each template is professionally formatted, fully editable, and includes guidance notes so your team can implement immediately.
Change Control Procedure
Complete SOP aligned with FDA 21 CFR 820.40, 820.30(i) & ISO 13485 §7.3.9. Covers initiation, review, approval, implementation, and closure.
Change Request Form
Standardized form capturing change description, rationale, affected products, risk classification, and required approvals.
Change Impact Assessment Template
Systematic evaluation of design, manufacturing, labeling, regulatory, and supply chain impacts for every proposed change.
Design Change Evaluation Checklist
Determine whether a change is significant vs. non-significant — critical for 510(k) submission decisions.
Change Verification & Validation Plan Template
Pre-built V&V plan ensuring every change is properly verified and validated before implementation.
Change Control Log
Centralized tracking log for all changes — ready for FDA audits and ISO surveillance reviews.
Built For Medical Device Professionals
Quality & Regulatory Teams
Ensure every change is documented, evaluated, and traceable — exactly how auditors expect.
R&D / Design Engineers
Quickly determine if your design change is significant and what verification is required.
Startups & Small Manufacturers
Stand up a compliant change control system without hiring a $200/hr consultant.
Get Audit-Ready Change Control — Today
One-time purchase. Instant download. Lifetime updates.
Trusted by quality teams at 100+ medical device companies