Medical Device FDA Regulatory Services
Yallow Life Sciences
Grow Your Medical Device Business to the U.S. Market
Yallow Life Sciences is a specialised FDA regulatory consulting firm for medical devices. We help medical device companies based in Europe and Norway to comply with the requirements of the U.S. Food and Drug Administration (FDA). Navigating the transition from EU MDR (2017/745) requirements to FDA regulations can be complex. We help to ensure your smooth and successful entry into the U.S. market. FDA-Compliance for medical device manufacturers in Europe.
To enter the U.S. market, manufacturers from Norway and the rest of Europe will have to:
- FDA Registration for Establishment
- Device Listing with FDA
- Designation of U.S. Agent
- FDA classification (Class I, II, III) compliance
- 510(k), De Novo, or PMA pathway submission
- FDA regulations are quite different than MDR and expert regulatory guidance is critical.
- Medical Device FDA Regulatory Services
Yallow Life Science Norway works with companies that need clarity in this process whether they are preparing for certification, responding to a Notified Body, or strengthening their internal systems.
1. Strategy for Entering the U.S. Market (Medical Devices)
We create a tailor-made FDA strategy:
- Classification of device (Class I, II, III)
- Regulatory pathway determination (510(k), De Novo, PMA)
- Gap analysis MDR to FDA
- Launch via U.S. regulatory route
2. Registration with the FDA & Assistance as a U.S. Agent
If you are outside the U.S.:
- FDA Establishment Registration
- Device List
- U.S. Agent Cover
Annual renewals, maintenance of compliance
3. 510(k) Submission (Class II Devices)
We offer comprehensive assistance with 510(k) submissions:
- Predicate device identification (US specific)
- Substantial equivalency strategy
- Preparation of technical documentation
- eSTAR Submission Help
- Handling FDA query response
4. De Novo Classification (New Devices)
New medical products:
- Regulatory strategy – De Novo
- Risk classification & reason
- Planning of clinical and non-clinical data
- Submission Preparation and FDA Interaction
5. Premarket Approval (PMA – Class III Devices)
For high risk medical devices:
- PMA Strategy & Planning
- Clinical Study Design & Support Services
- Scientific documentation FDA meetings & submissions management
6. QMS Alignment (ISO 13485 to FDA QSR)
We connect European and U.S. quality systems:
- Gap analysis ISO 13485 vs 21 CFR Part 820
- FDA Compliance QMS Restructuring
- Development of SOPs
- FDA Inspection Preparedness
7. Technical Documentation Conversion (EU à FDA)
We customise your MDR documentation to FDA format:
- Technical file to 510(k)/PMA format
- Alignment on risk management
- FDA Standards (Labelling and IFU Compliance)
- Adaptation of clinical data
8. Market Compliance (FDA)
We remain compliant after approval:
- Medical Device Reporting (FDA MDR)
- Systems for handling complaints
- CAPA management
- Recall and vigilance are supportive of
Why Yallow Life Sciences?
- Expertise in medical device regulatory consulting
- Dual compliance EU MDR + FDA.
- Strong backing for Norway & European manufacturers
- Fast, efficient FDA submission process
- Full lifecycle regulatory support
We support your international growth with confidence, remaining compliant every step of the way.
The way we work
- Regulatory Gap Analysis EU vs. FDA
- FDA Strategy Development Documentation Preparation & Translation
- Submission & FDA Interaction
- Post-market surveillance