About Dr. Giuseppe S. Pierno
MDR compliance consulting for small medical device manufacturers.
I spent fourteen years as a consultant across different sectors before specialising in regulatory compliance for medical devices. That diversified background gives a practical perspective on a subject often treated only in the abstract: I have seen how small companies actually work, and how compliance succeeds — or fails — inside them.
Complimed exists to serve small and micro manufacturers — the companies large consultancies tend to overlook.
Credentials
Expertise and Qualifications
Physics graduate with 14 years of professional experience, specialising in medical device regulatory affairs and quality management systems. Qualified to serve as Person Responsible for Regulatory Compliance (PRRC) under Article 15 of MDR 2017/745.
- MDR 2017/745
- ISO 13485:2016 — quality management systems
- ISO 14971:2019 — risk management
- Technical documentation (Annexes II and III)
- EUDAMED registration
- Clinical evaluation
- Post-market surveillance and vigilance
Focus
Why Small Manufacturers
Large consultancies concentrate on large clients — the economics of their structure demand it. Yet the most innovative devices often come from small teams, and a small team should not be priced out of competent regulatory support. That gap is the reason this practice exists.
Approach
How I Work
Pragmatic, not bureaucratic
Documentation that serves compliance — not paperwork for its own sake.
Transparent and educational
You should understand why something is required, not just that it is.
Tailored, not standardised
Deliverables sized to your device and your team — not templates sold by the kilo.
Long-term relationship
Compliance is not a one-off event. I stay reachable after the deliverable.
Knowledge transfer
Beyond Consulting
Knowledge transfer is part of the service: training for your team, reusable tools and templates, and ongoing support when you need it. Many clients start with full support and then maintain compliance on their own — that is a good outcome, not a lost client.
Let’s Talk
Free 30-minute initial consultation · info@complimed.eu · Response within 24 hours
Regulatory information last reviewed: 10 August 2026