Medical Device Startup Launch Toolkit
Six launch readiness checklists for medical device startups — QMS foundation, regulatory pathway confirmation, design controls go-live, pre-shipment compliance, manufacturing readiness, and RA resource planning.
What You Get
QMS Foundation Readiness Checklist (ISO 13485 + QMSR)
Pre-launch QMS readiness checklist covering the 12 core QMS elements required before first device shipment. Covers document control, records management, management responsibility, training, design controls, production controls, CAPA, and internal audit. Each item includes the specific evidence FDA and ISO 13485 auditors look for during initial certification audits.
Regulatory Pathway Confirmation Checklist
Checklist for confirming your regulatory pathway is correct and your submission timeline is realistic before committing engineering resources. Covers classification confirmation, predicate verification, NSE risk assessment, IDE determination, and the go/no-go criteria that prevent startups from discovering a fundamental regulatory error six months into development.
Design Controls Go-Live Checklist (21 CFR 820.30)
Complete checklist for confirming design controls are properly implemented before starting formal design work. Covers design planning, design input capture, design output requirements, design review cadence, verification and validation planning, and design transfer requirements. Structured so startups implement design controls correctly from day one rather than retrofitting after development.
First Device Launch Pre-Shipment Checklist
Comprehensive pre-shipment readiness checklist for first commercial device launch. Covers device labeling compliance (21 CFR Part 801), UDI label verification, device registration (FDA 510(k) clearance or exemption confirmation), facility registration, complaint handling activation, MDR reporting activation, and the distribution controls required before first shipment.
Manufacturing Readiness Assessment Template
Structured assessment for confirming manufacturing is ready for production launch. Covers production equipment qualification, process validation status, incoming inspection activation, nonconforming product controls, batch/lot record system, environmental controls, and personnel training verification. Pre-formatted for management sign-off before first production run.
Regulatory Affairs Startup Resource Planning Template
Resource planning template for building a regulatory affairs function from scratch. Covers RA staffing model options (in-house vs consultant vs hybrid), regulatory budget by milestone (510k, ISO 13485, EU MDR), timeline dependencies between regulatory and product development milestones, and the prioritization framework for resource-constrained startup RA programs.
FAQ
When should a medical device startup implement a QMS?
Before design and development begins. Retrofitting a QMS after product development is significantly more expensive and creates design history file gaps that FDA flags during 510k review and pre-market inspections.
Does a startup need an ISO 13485 certificate before 510k submission?
Not for FDA 510k submission. ISO 13485 certification is required for EU MDR CE marking but optional for US market access. However, FDA will inspect your QMS before approving a PMA and may inspect Class II manufacturers after 510k clearance.
What format are the documents?
All documents are editable Word and Excel checklists ready for direct use.
Ready to get started?
For informational purposes only. Not legal or regulatory advice. Legal