Safety that accelerates approvals — and stands up to audits.
I help device companies design, document, and defend safety across the product lifecycle: from risk management and CER/PMCF to vigilance and health‑authority queries. Fast, rigorous, and inspection‑ready.
Selected impact
- Led vaccine safety surveillance generating 7,000‑page submissions for regulators.
- Safety lead for Medtronic spine devices & adjunct biologics; ran RCT medical safety and post‑market vigilance.
- Created a consolidated CER model that cut resource use by ~65% and streamlined renewals.
- Implemented reporting protocols saving ~$1.5M annually while improving time‑to‑signal.
What I do
Clear deliverables, clear timelines.
Risk Management
Risk policy, risk management plan, hazard analysis, FMEA/FMECA, and risk‑benefit.
EU MDR Clinical Evaluation
CER authoring/updates (MEDDEV 2.7/1 rev.4 & MDR Annex XIV), literature plans/reviews, PMCF plans/reports.
Post‑Market Surveillance
PMS reports, PSUR, signal detection and management, benefit‑risk updates, MAUDE/EUDAMED trending, customer complaint analytics.
Vigilance & Field Actions
Serious incident assessment, Impact Issue Assessment (IIA), reportability decisions, narratives, and FSCA communications support.
HAQ/Deficiency Responses
Rapid, evidence‑based responses to FDA/Notified Body questions; gap remediation plans and traceability mapping across QMS, RMF, CER, and IFU.
Clinical Safety Governance
Safety monitoring (AE/SAE medical review), DSMB/S极MT charters, protocol safety language, investigational plan inputs for combination products.
Client Success Stories
What medical device professionals say about working with me
Dr. Bordany transformed our risk management documentation, making it audit-ready in just three weeks. His expertise in both clinical and technical aspects is exceptional.
We were struggling with MDR compliance until we engaged Dr. Bordany. His CER and PMCF strategies were exactly what we needed for notified body approval.
His vigilance system implementation not only improved our compliance but saved us significant resources. The ROI was evident within the first quarter.
Trusted By Industry Leaders
Partnering with innovative companies across the healthcare spectrum
A simple, high‑conversion engagement process
Built to minimize your effort and maximize regulatory readiness.
FREE Discovery
30‑min intake to map device, claims, markets, timelines, and pain points. NDA available.
Rapid Assessment
Gap review across RMF/CER/PMS, producing a red‑yellow‑green scorecard and prioritized actions.
Remediation Sprints
Fixed‑fee sprints for each deliverable (e.g., CER update + PMCF plan) with weekly check‑ins and version control.
Outcomes & proof
Global vaccine surveillance
Led one of the largest vaccine safety programs; authored multi‑thousand‑page submissions and navigated complex health‑authority interactions.
Spine devices & biologics
Medical safety lead for implantables and rhBMP‑based adjuncts; ran RCT safety and scaled post‑market vigilance programs.
Efficiency, not just compliance
Consolidated CER approach cut resource use ~65%; revamped reporting processes saved ~$1.5M/year while improving oversight.
FAQ
Can you take over our CER/PMCF on short notice?
Often, yes. The discovery + rapid assessment phases are designed to triage quickly, then we execute sprints focused on highest‑risk gaps first.
What markets and device classes?
EU MDR and FDA for implantables, active devices, and combination products across Class I–III (US) / Class I–III (EU).
How do you handle confidentiality?
Mutual NDAs and secure collaboration (version control, auditable edits, restricted access). I can work within your DMS or set up a dedicated workspace.
Do you work with Notified Bodies directly?
Yes, I prepare responses and support during audits to ensure your documentation meets all regulatory requirements.
Let’s talk about your device
Send a quick note with your device type, market(s), and target timeline.
All guidance is provided for regulatory and scientific purposes and does not constitute legal advice.