Interim Quality & Regulatory consulting for medical device manufacturers: QMS, MDR remediation, CAPA and documentation.
Leibinger Consulting
Mühlheim an der Donau, GermanyNew on Amplifa
About Leibinger Consulting
Leibinger Consulting is the sole proprietorship of Patrick G. Leibinger, Interim Quality & Regulatory Consultant for medical device manufacturers. The offering covers MDR remediation, establishing and audit-preparing quality management systems according to ISO 13485, internal audits, CAPA management and complaint handling (Complaints, Vigilance, NC/QN) as well as technical documentation (MPD/MPI) and supporting work for FDA 510(k) approvals. In addition, process validation, production transfer, feasibility checks, supplier quality (QAA) and manufacturing optimization are offered. The approach is implementation-oriented: procedures, work instructions, inspection plans and CAPA actions are not only recommended but created and implemented directly. Patrick G. Leibinger has been gaining experience in medical technology since 1993 — from surgical instrument mechanic through leadership positions in medical device apparatus manufacturing to his own OEM companies for orthopedic and trauma products. Clients have included Stryker, DePuy Synthes, Johnson & Johnson, Abiomed, Karl Storz and Ulrich AG. The location is Mühlheim an der Donau; the area of activity is Germany, the EU and the USA.
- Site
- Mühlheim an der Donau
- Processes
- QMS establishment & audit preparation (ISO 13485, internal audits, harmonization), CAPA management & complaint handling, MDR remediation & technical documentation (MPD/MPI, 510(k) support), Process validation, production transfer, supplier quality (QAA), MDR remediation, Interim Quality & Regulatory, QMS establishment & audit preparation (ISO 13485), Internal audits
- Materials
- QMS Establishment & Audit Preparation (ISO 13485), CAPA Management & Complaint Handling, MDR Remediation & Technical Documentation, Process Validation & Supplier Quality
- Employees
- 1
- Industries
- Medical technology / Medical device manufacturers
- 01
GAP analysis of the system, process and physical product
- 02
Root-cause analysis
- 03
Creation and implementation of procedures, inspection plans and CAPA actions
- 04
MDR-compliant, audit-ready documentation
- 05
Effectiveness verification and knowledge transfer
Services & Methods
QMS Establishment & Audit Preparation (ISO 13485)
Establishment, harmonization and review of the quality management system including internal audits.
CAPA Management & Complaint Handling
Root cause, corrective and preventive actions, effectiveness verification as well as complaints, vigilance and NC/QN management.
MDR Remediation & Technical Documentation
MDR remediation, technical documentation (MPD/MPI) and supporting work for FDA 510(k) approvals.
Process Validation & Supplier Quality
Process validation, manufacturing optimization, production transfer and supplier quality (QAA).
Location
Mühlheim an der Donau
DEOffice/Headquarters
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| QMS establishment & audit preparation (ISO 13485, internal audits, harmonization)Inspection | – | – | – | – | – |
| CAPA management & complaint handlingInspection | – | – | – | – | – |
| MDR remediation & technical documentation (MPD/MPI, 510(k) support)Engineering | – | – | – | – | – |
| Process validation, production transfer, supplier quality (QAA)Engineering | – | – | – | – | – |
Additional services
Reference customers
Background
- 1993
Start of activity in medical technology; career from surgical instrument mechanic through leadership roles in medical device apparatus manufacturing to his own OEM companies for orthopedics and trauma