Your QMS audit-ready. Your CAPA backlog cleared. Implemented — not just analyzed.
I uncover hidden risks in your QMS, processes, and documentation — and close the gaps myself, instead of just naming them. With the rare combination of manufacturing and regulatory expertise.
Especially relevant when the EUDAMED registration obligation in force since May 2026, the legacy-device deadline of 28 November 2026, or the expiring MDR transition periods (end of 2027 / 2028) are already bearing down on you.
Compliance is decided on the floor, not in the binder.
Certification backlog, MDR remediation, growing CAPA backlogs — and a team already at its limit. Most consultants deliver analyses. What's missing are hands that implement.
Paper ≠ Practice
Auditors check whether the documented processes match reality on the shop floor. That's exactly where findings originate.
The Backlog Grows
Every month adds to the CAPA, complaint, and NC backlog — and with it the audit risk. Waiting is the most expensive option.
No Capacity
Specialists with MDR experience are scarce, and a permanent hire takes months. No fast fix for an acute gap.
Personal Risk
A finding doesn't just hit the process — it hits you. As the responsible person, you're on the line before management, the notified body, and your own team.
"Quality means doing it right when no one is looking." — Henry Ford
From "should" to done — four phases that close the gap.
Every phase deliberately starts at development and ends in the framework — where pure paper consultants (theorists) and pure technicians (practitioners) stop.
Baseline Diagnosis
GAP analysis directly at the system, the process, the workflow, and the physical product — not just the binder.
instead of a paperwork auditRoot Cause at the Source
Root cause where it originates: material, process, manufacturing variation, supplier-driven inconsistencies.
instead of symptoms on paperClose It Myself
Procedures, work instructions, and inspection plans created; CAPA/SCAR implemented.
instead of only recommendingVerifiable Records
Complete, MDR-compliant documentation that holds up in the audit.
instead of "compliant on paper"What manufacturers bring me in for.
QMS Setup & Audit Preparation
Setup, harmonization, and review of the quality management system — audit-ready because it's lived.
CAPA Management & Complaint Handling
Root cause, corrective and preventive actions, effectiveness checks, QN/NC management.
MDR Remediation & Technical Documentation
MDR remediation, technical documentation, review, and support for US submissions.
Process Validation & Supplier Quality
Process validation, manufacturing optimization, production transfer, supplier quality (QAA).
Patrick G. Leibinger
In medical devices since 1993 — over 30 years, spanning a continuous arc from surgical instrument maker through entrepreneurship to specialized interim consulting for manufacturing, quality & regulatory: from idea to finished product.
From manufacturing surgical instruments, through leading medical device apparatus engineering, to my own companies for OEM products in orthopedics and trauma. That's why I read the physical product and the regulatory framework in equal measure.
- Stryker
- DePuy Synthes
- Johnson & Johnson
- Abiomed
- Karl Storz
- Ulrich AG
Held mandates and roles. Additional clients confidential at their request.
Audit-Ready Check: Shelf Life & Storage
Materials with limited shelf life and their storage conditions are an underestimated audit area. In 3 days I analyze your system data, processes, and workflows on a sample basis for consistency and gaps — before an auditor finds them.
- Sample-based analysis of system data & processes for consistency
- Identification of gaps with risk rating
- Final report with prioritized actions
Two starting points, two outcomes.
Production Transfer & Feasibility
Work plans, drawings, and the actual manufacturing flow had diverged — a risk for transfer and audit.
Full GAP analysis across all production lines, revised and newly created documentation, prioritized action plan.
CAPA Shelf Life & Storage
Materials with limited shelf life without consistent data and process control — a latent audit finding.
Root cause analysis, implemented corrective and preventive actions, audit-proof evidence documentation.
Anonymized project examples from real mandates.
What decision-makers clarify before reaching out.
How are you different from a classic consultant?
I don't deliver an analysis to file away — I revise and create procedures, inspection plans, and CAPA actions myself, at the process and at the physical product. The knowledge stays in your house, not with me.
How long is the ramp-up?
Short. I come from manufacturing surgical instruments and was a manufacturer myself — I don't need to learn your world first. I'm typically productive on your open items from the first week.
What does the engagement look like contractually?
Deliverable-based projects with a clearly defined scope and outcome — clean with respect to worker-classification rules and without an open-ended hourly meter. You know what you're getting before the project starts.
Are our data and documents safe with you?
Confidentiality is a baseline requirement in this business — on request with an NDA before the first substantive conversation. Including OEM and contract manufacturing.
What if my team is skeptical about outside support?
I work with your team, not over their heads. Your people know the workflows — I bring capacity and the outside view. The goal is always to hand over knowledge, not to create dependency.
You're a solo consultant — what if you're unavailable?
Every project is documented so the current state can be handed over at any time — that's part of the method, not an extra. That's exactly what separates lived quality work from single-point-of-knowledge monopolies.
Let's talk about your next audit.
A short intro call clarifies whether and how I can help — no obligation, no sales pressure.
Send an email