🔷 HERO SECTION
Clinical Evaluation Report (CER) Consulting — Done Right, Done Fast
Senior MDR & FDA Expertise for Medical and Dental Manufacturers
I help US and EU manufacturers develop, fix, and defend Clinical Evaluation Reports (CERs) that withstand notified body and regulatory scrutiny — without hiring a full-time regulatory director.
✔ MDR-ready CERs
✔ Gap analysis & remediation
✔ Short, high-impact engagements
👉 Book a 30-minute CER diagnostic call
🔷 WHAT I DO (SERVICES)
Clinical Evaluation Report (CER) Support
• CER gap analysis (MDR Annex XIV)
• Literature strategy & evaluation
• Technical–clinical alignment
• Reviewer-ready CER structure
• Notified body comment remediation
Ideal for:
Manufacturers facing MDR transition, NB questions, or internal bandwidth limits.
🔷 ISO 13485 & Technical Support (Secondary)
• ISO 13485 readiness & internal audits
• Technical documentation alignment
• Risk management & clinical linkage
(Available once CER engagement is established.)
🔷 WHY WORK WITH ME
• 30+ years in medical & dental materials, R&D, and regulatory affairs
• Hands-on experience with EU MDR and FDA environments
• Senior-level judgment — not junior template work
• Focus on clear outcomes, not billable chaos
I typically engage for 2–4 weeks to solve specific regulatory problems quickly.
🔷 HOW ENGAGEMENTS WORK
1. 30-min diagnostic call (focused, no selling fluff)
2. Fixed-price proposal within 24 hours
3. Delivery in 2–4 weeks
4. Optional ongoing regulatory support
Typical CER engagements:
💼 $4,000 – $6,000 depending on scope
🔷 WHO I HELP
• EU manufacturers transitioning to MDR
• US companies preparing EU market entry
• Dental & medical device SMEs
• Companies without an internal CER expert
• Teams facing notified body pushback
🔷 CALL TO ACTION
Need CER support now?
Email me directly or book a short diagnostic call.
📧 jorg@jota-tech.com
📱(714-713-7718)