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Medical device regulatory support
We help medical device companies organize and prepare the documentation behind FDA registration, listing, submissions, and ongoing compliance.
FDA registration and device listing
Support identifying registration and listing requirements, gathering the information needed, and keeping records current.
What's included
- Establishment registration support
- Device listing support
- Annual registration renewals
- Product and classification records
- Updates when operations change
- Recordkeeping
Submission support and reports
Preparation support for FDA submissions, working alongside your engineering, quality, and regulatory teams.
What's included
- 510(k) submission preparation support
- Regulatory pathway research
- Submission documentation and reports
- Technical documentation support
- Test report organization
- Completeness review
Regulatory compliance support
Practical help keeping your documentation, processes, and records aligned with applicable FDA requirements.
What's included
- Compliance gap assessments
- Quality system documentation
- Document control support
- Labeling review support
- Complaint and records documentation
- Inspection readiness
Regulatory strategy and readiness
For startups and growing manufacturers, early clarity saves time. We help plan what to prepare, and when.
What's included
- Pathway and classification research
- Documentation gap mapping
- Readiness planning
- Timeline planning
About FDA terminology. Vita Tech provides regulatory support and consulting services. FDA establishment registration and device listing do not mean a device is FDA approved or cleared, and submission support does not guarantee any FDA decision.
Preparing a device for the U.S. market?
Tell us where you are in development and what documentation you have today, and we'll help you understand what comes next.