US & EU Medical Device Regulatory & Market Access Consulting

Expanding a medical device into the US or European market requires more than regulatory approval. It demands a joined-up strategy that aligns regulatory compliance, market access, reimbursement, and commercial adoption from the outset.

Simplimedica supports:

UK & EU companies entering the US market
US companies expanding into Europe

We act as a regulatory and commercial bridge between jurisdictions — reducing risk, rework, and time to revenue.

FDA & EU MDR Regulatory Strategy

We deliver jurisdiction-specific regulatory support, not document conversions.

Regulatory services include:

FDA 510(k), De Novo, and PMA submission support
EU MDR Technical Documentation (Annex II & III)
Design Controls aligned to 21 CFR 820 / QMSR
Risk management per ISO 14971
Clinical and post-market strategy alignment
FDA Pre-Sub and Notified Body readiness

Focus: Submissions designed to survive review — not just reach it.

Market Access, Commercialisation & Reimbursement

Approval alone does not guarantee adoption. We help ensure devices are designed, evidenced, and positioned for real-world use.

Market access support includes:

US vs EU market entry and sequencing strategy
Intended Use and claims aligned to adoption and reimbursement
Stakeholder and payer landscape assessment
Early reimbursement pathway and risk analysis
Commercialisation planning grounded in regulatory reality

Focus: Regulatory success that translates into sustainable revenue.

Commercialisation Planning

Commercial success depends on designing for adoption, not retrofitting later.

We support:

Go-to-market strategy aligned to regulatory constraints
Clinical evidence planning to support adoption, not just approval
Pricing logic grounded in clinical and economic value
Early commercial risk identification (training burden, workflow impact, adoption barriers)
Scale-up readiness from pilot to broader deployment

Outcome: Devices designed for real-world use — not just regulatory clearance.

One Strategy — Not Silos

We deliberately integrate:

Regulatory claims ↔ clinical evidence ↔ reimbursement logic
Design decisions ↔ commercial constraints
Approval strategy ↔ post-market adoption

This prevents costly pivots after approval and strengthens investor, payer, and regulator confidence.

Why Simplimedica

✔ Specialist in high-risk, implantable, and innovative devices
✔ PMA-level thinking applied early
✔ Startup-aware, scale-ready delivery
✔ Deep understanding of FDA and EU MDR expectations
✔ Built for companies expanding globally

Who We Support