Regulatory
Medical Device Submissions: 510(k), De Novo and PMA
Selecting and executing the right FDA medical device pathway - 510(k), De Novo, or PMA - depends on risk, predicate strategy, and clinical evidence. Viltis supports regulatory strategy, documentation…
The client situation
- First US submission planning
- Pathway uncertainty or predicate challenges
- Substantial completion of design/clinical evidence
How Viltis helps
Structured support, end to end
01
Step 1
Pathway strategy
02
Step 2
Content planning and gap analysis
03
Step 3
Authoring and reviewer coordination
04
Step 4
AI/deficiency response support
Selecting and executing the right FDA medical device pathway - 510(k), De Novo, or PMA - depends on risk, predicate strategy, and clinical evidence. Viltis supports regulatory strategy, documentation planning, and submission packaging for device organizations.
Typical deliverables
What engagement can produce
Strategy memo
Submission outline
Module drafts and checklists
FAQ
Common questions
Do you only support FDA?
US device pathways are the focus of this page; EU MDR/IVDR and global planning are available through related regulatory services.
Related proof
Manufacturing, Quality and Process Team
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Need support with Medical Device Submissions: 510(k), De Novo and PMA?
Discuss this requirement with our team - scope, timeline, and delivery model.