Map
Classification, predicate and testing strategy with clear milestones and owners.
FDA
FDA QMSR and 510(k) strategy and submissions
Map the right pathway, align QMSR evidence with your design controls and deliver a 510(k) package reviewers can navigate quickly.
Right pathway
Classification and predicate strategy that fits your device
Classification and predicate strategy that fits your device
QMSR alignment
Design controls and records mapped to requirements
Design controls and records mapped to requirements
Reviewer friendly
Well indexed sections and traceability
Well indexed sections and traceability
Faster responses
Clear answers and updates for additional information requests
Clear answers and updates for additional information requests
Scope
What we execute and what you receive
We connect QMSR evidence to your submission plan so reviewers see a complete and consistent story.
QMSR activities we align
- Classification and regulatory strategy
- Design and development planning with traceability
- User needs, design inputs and verification planning
- Risk management links to ISO 14971
- Software documentation when applicable
- Supplier controls for critical components
- Production controls and process validation strategy
- Labeling and UDI considerations
- Complaint handling, PMS and CAPA readiness
510(k) submission package
- Indications for use and device description
- Predicate comparison and substantial equivalence rationale
- Standards and guidance mapping
- Bench testing plan and reports
- Biocompatibility and sterilization as needed
- Software documentation per level of concern
- Electrical safety, EMC and usability summaries
- Labeling set and UDI approach
- Administrative forms and eCopy assembly
How it works
From pathway to clearance step by step
We align the plan with your device and timeline so each activity builds submission ready evidence.
Build
Generate and clean evidence, align QMSR records and assemble sections with traceability.
Submit
eCopy assembly, responses for AI letters and updates through clearance.
FAQ
Common questions
How do we choose the right predicate?
We review classification, indications and technology to build a predicate rationale that positions your device appropriately.
Can you work with our test labs and schedule?
Yes. We coordinate plans and reports for bench, biocompatibility, sterilization and electrical safety to fit your timelines.
Do you handle software documentation?
Yes. We prepare the required software level documentation and align it with risk, verification and cybersecurity expectations.
What support do you provide after submission?
We organize responses to additional information requests and update sections so reviewers can close issues quickly.
Ready to map your FDA pathway?
Book a quick call to align strategy, deliverables and dates for your device and markets.