ISO 13485 ┬À ISO 9001 ┬À GMP ┬À Risk Management ┬À Medical Devices ┬À EU MDR ┬À FDA
Andreas Spitzer
Global Quality Management Consultant
Delivering precision quality systems for the global medical device industry ÔÇö 8+ years of hands-on expertise.
Currently accepting new mandates ÔÇö available globally for on-site and remote engagements.
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About Me
With over 8 years of experience in Quality Management, I support medical device companies worldwide in building and maintaining robust Quality Management Systems in compliance with ISO 13485, ISO 9001, and GMP standards.
Starting my career in aviation engineering, I transitioned into the medical device industry in 2017 — driven by the conviction that precision and compliance are not obstacles, but the foundation of products that save lives.
As a freelance consultant, I offer something that large consulting firms cannot: direct, unmediated expertise. No account managers, no junior staff — you work with me directly, at every stage of the project. Whether I'm building a QMS from scratch, preparing your team for a notified body audit, or stepping in as interim Head of Quality, you get the same thing every time: one experienced professional, fully committed to your outcome.
Certifications
- Quality Management Representative ISO 13485:2016
- Risk Management for Medical Devices ISO 14971:2019
- Internal Auditor ISO 13485:2016
What Sets Me Apart
Eight years. Three languages. One focus.
- TÜV Süd Academy — Representative for Quality Management in the Medical Device Industry (2020)
- ISO 13485 · ISO 9001 · GMP
- 8+ Years Industry Experience
- Fluent in English, German & Spanish
- Available Globally
Specialized, Not Generalized
I don't consult on everything. My focus is Quality Management for medical device companies — deep, sector-specific expertise, not generalist advice.
An Engineer's Mindset
My background in aviation engineering is a differentiator. Aviation and medical devices share the same non-negotiable: when systems fail, lives are at stake. That precision and discipline shapes everything I do.
Freelance Means Full Focus
No account managers, no junior consultants, no handoffs. When you work with me, you work with me — one experienced person, fully accountable for the outcome.
Truly International
Fluent in English, German, and Spanish — I work with companies across Europe, Latin America, and beyond. Direct communication in the language your team speaks.
Available When You Need It
QMS gaps don't wait for convenient timing. I'm available for rapid deployment — globally, without the onboarding overhead of a large consultancy.
References
Companies I have worked with across the medical device industry.
Experience
A career built on precision — from aviation engineering to leading quality systems in the global Medtech industry.
Entry into Medical Device Industry — Service Coordinator
Swissray International
First role in the medical device industry, gaining hands-on experience with service coordination, technical documentation, and the regulatory environment of medical imaging equipment.
Product Quality Engineer
Roche Diagnostics International AG
Quality engineering role at a global diagnostics leader — responsible for product quality processes, deviation management, and supplier quality across international manufacturing sites.
Quality Assurance Specialist (ad interim)
Qmedics AG
Growing quality assurance responsibility at a Swiss Medtech company. Management of the complete QMS and leadership of internal and external audits.
Head of Quality Management & QMB
Qmedics AG
Leading the quality management function and serving as Quality Management Representative (QMB). Ensuring ongoing ISO 13485 compliance and full QMS responsibility.
Freelance Quality Management Consultant
QM-Service
Independent freelance quality management consultancy serving medical device companies across Europe and beyond — specializing in ISO 13485 QMS implementation, audit preparation, gap analysis, CAPA management, and interim quality leadership.
Services
Tailored quality management solutions for the medical device industry — from initial assessment to ongoing compliance support.
QMS Implementation
Building and structuring compliant Quality Management Systems from the ground up, tailored to ISO 13485 and ISO 9001 requirements.
Internal Audits
Thorough, systematic internal audits to identify gaps, ensure compliance, and prepare your organization for external certification audits.
Gap Analysis
Structured assessment of your current QMS against regulatory requirements — clear action plans.
CAPA Management
Implementing effective Corrective and Preventive Action processes to eliminate root causes and prevent recurrence.
Documentation & SOPs
Creating, reviewing, and maintaining all QMS documentation in line with regulatory standards and operational needs.
Frequently Asked Questions
ISO 13485 is the international quality management standard specifically designed for the medical device industry. It sets out requirements for a QMS that ensures consistent design, development, production, and delivery of medical devices that are safe and effective. For most markets — including the EU (MDR), Canada (MDSAP), and Japan — ISO 13485 certification is a prerequisite for market access, not a nice-to-have.
ISO 9001 is a general quality management standard applicable to any industry. ISO 13485 is a sector-specific standard built on similar principles but with additional requirements tailored to medical devices — including risk management (ISO 14971), regulatory compliance, traceability, and post-market surveillance. Companies in the Medtech space need ISO 13485, not ISO 9001, for regulatory purposes — though the two can coexist.
It depends on the starting point. A company with no existing QMS infrastructure should expect 9–18 months to reach certification readiness. A company with an existing ISO 9001 system can typically transition in 4–9 months. The timeline is driven by the complexity of your product portfolio, the size of your organization, and how efficiently documentation and process gaps are addressed. Early involvement of an experienced consultant shortens this significantly.
Yes. Audit preparation is one of the most time-sensitive QMS challenges a company faces. I can step in to conduct a thorough internal audit, identify gaps against the applicable standard, prioritize corrective actions, and prepare your team for the audit process — whether it's a notified body audit, a customer qualification audit, or an FDA inspection. The earlier I'm involved, the better the outcome.
Both. Startups entering the Medtech space benefit enormously from building their QMS correctly from day one — it avoids costly rework and accelerates their path to market. Established companies typically need QMS optimization, gap closure, or interim quality leadership. The approach differs, but the standard of work does not.
CAPA stands for Corrective and Preventive Actions. It is the engine of a functioning QMS: when something goes wrong — a non-conformity, a complaint, an audit finding — CAPA ensures the root cause is identified, addressed, and prevented from recurring. Regulators look closely at CAPA systems because a weak CAPA process is a strong indicator of a weak quality culture. A well-run CAPA system turns problems into permanent improvements.
Yes. If your quality leadership position is vacant — due to a resignation, a parental leave, or a restructuring — I can step in on an interim basis to maintain regulatory compliance, lead audits, manage your QMS, and ensure continuity while you find a permanent solution. I have held this role before and understand what it takes to keep a quality department running under pressure.
ISO 13485 and the EU MDR (Regulation 2017/745) are complementary but distinct. ISO 13485 is a QMS standard — it defines how your quality management system should be structured and operated. The EU MDR is a regulatory framework — it defines what technical documentation, clinical evidence, and post-market surveillance are required to CE-mark a medical device. ISO 13485 certification does not automatically mean MDR compliance, but a well-implemented ISO 13485 QMS provides the structural foundation for meeting MDR requirements. Companies targeting the EU market need both: a certified QMS and MDR-compliant technical files.
An initial consultation is a focused, no-obligation conversation — typically 45–60 minutes, by video call or phone. I'll ask about your regulatory markets, product portfolio, current QMS status, upcoming audit dates, and what's driving the need for external support. By the end of the call, you'll have a clear picture of your compliance gaps, the scope of work required, and how I can help — with no commitment on either side. If we're a good fit, we agree on the next steps.
Let's Work Together
Ready to elevate your QMS to the next level? I'm available for new mandates and happy to discuss your project in a no-obligation initial consultation.