ISO 13485 Certification Consulting in Germany
We provide professional ISO 13485 certification consulting in Germany, helping medical device organizations implement compliant quality management systems and pass certification audits with confidence.
Get ISO 13485 Certified With Proven Expertise
We guide medical device manufacturers and suppliers through every step of ISO 13485 certification. From gap analysis and documentation to internal audits and audit preparation, our approach is practical, regulatory-aware, and built to meet EU expectations. Strengthen compliance, reduce audit risk, and achieve certification efficiently.
Start Your Certification Journey
Tell us about your organization and receive a detailed quote within 24 hours
✓ No obligation consultation
✓ Medical device QMS expertise
✓ Response within 24 hours
- ISO 9001 Expertise
- Certified Consultants
- Proven Implementation Framework
- Trusted by Businesses
What ISO 13485 Certification Means for Your Business
ISO 13485 is specifically designed for organizations operating within the medical device sector. Unlike general quality standards, it places strong emphasis on regulatory compliance, risk management, validation, and traceability throughout the product lifecycle.
ISO 13485 certification helps your organization:
- Meet EU MDR and international regulatory expectations
- Establish a compliant medical device quality management system
- Improve product safety, consistency, and process control
- Strengthen trust with regulators, notified bodies, and customers
- Support market access in Germany and global markets
Our ISO 13485 consultants in Germany ensure your system aligns with both ISO requirements and regulatory audit expectations.
Our ISO 13485 Certification Consulting Services
We support organizations throughout every stage of the ISO 13485 certification process with structured, audit-focused consulting services.
ISO 13485 Gap Analysis
We assess your existing processes and documentation against ISO 13485 requirements to identify compliance gaps, regulatory risks, and improvement opportunities.
Quality Management System Implementation
We develop and implement an ISO 13485-compliant quality management system tailored to your medical device activities, organizational structure, and regulatory obligations.
Process Mapping & Documentation
Our consultants support the creation and optimization of required documentation, including quality procedures, risk management files, validation records, and supplier controls.
ISO 13485 Internal Audits
We conduct ISO 13485 internal audits to verify system compliance, identify non-conformities, and prepare your organization for certification audits.
Improved Quality Control
Establish robust processes that consistently deliver high-quality products and services.
Increased Customer Trust
Demonstrate your commitment to quality and build confidence with stakeholders.
Better Process Efficiency
Streamline operations, reduce waste, and optimize resource utilization.
Global Market Recognition
Access international markets with a globally recognized quality standard.
Expert Solutions for Medical Device Quality Management
ISO 13485 certification is widely expected in Germany for organizations operating within the medical device and healthcare sector, particularly those subject to regulatory oversight and external audits.
Our ISO 13485 consulting services support:
- Medical device manufacturers
- In-vitro diagnostic (IVD) companies
- Medical software and digital health providers
- Component suppliers and contract manufacturers
- Service providers within the medical device lifecycle
Our consultants understand German and EU regulatory expectations, medical device documentation requirements, and audit practices — ensuring your ISO 13485 quality management system is compliant, practical, and audit-ready.
About Our Expert Consultants
Our team consists of experienced ISO 13485 consultants with deep expertise in medical device quality management systems, regulatory compliance, and audit preparation.
We support organizations from initial gap analysis through certification audits, ensuring alignment with ISO 13485 requirements, EU MDR expectations, and accredited certification bodies. Our consultants combine regulatory knowledge with practical implementation experience to deliver sustainable, long-term compliance.
Medical device–focused expertise
Deep regulatory and audit knowledge
International ISO standards experience
Jonathan Sternberg
- Sternberg Consulting
If you’re looking for expert ISO 13485 certification support in Germany, Sternberg Consulting is ready to guide you.
Jonathan Sternberg is an experienced ISO 13485 consultant, certified internal auditor, and external QMR, supporting medical device organizations across Germany. He guides companies through ISO 13485 implementation and certification with clarity, precision, and regulatory confidence.
Our pricing reflects real certification effort, audit preparation, and long-term compliance support — with clearly defined service packages and no hidden costs.
Pro Tip:
Look beyond price. Consultant experience, audit support, and certification-body knowledge make the difference.
ISO 13485 Certification Process – How It Works
Assessment & Scope Definition
Evaluate medical device activities and define certification scope.
QMS Development & Implementation
Implement ISO 13485 compliant quality management system.
Internal Audit & Audit Preparation
Verify compliance and address identified gaps.
Certification Audit & Ongoing Compliance
Support certification audits and maintain regulatory compliance.
ISO 13485 Certification in Germany
ISO 13485 certification is widely required for medical device companies operating in Germany and the European Union, particularly for CE marking, regulatory submissions, and cooperation with notified bodies.
We support organizations across Germany, including Berlin, Munich, Hamburg, Frankfurt, Stuttgart, Cologne, and Dresden, with ISO 13485 certification consulting aligned with German and EU regulatory expectations.
Who We Support
Our ISO 13485 consulting services are suitable for:
- Medical device manufacturers
- Medical device suppliers and service providers
- In-vitro diagnostic (IVD) organizations
- Medical software and digital health companies
Whether you are pursuing ISO 13485 certification for the first time or transitioning from another standard, we tailor our approach to your product scope and regulatory requirements.
Start Your ISO 13485 Certification Journey Today
If you are looking for expert ISO 13485 certification consulting in Germany, Sternberg Consulting is ready to support your organization with structured guidance and regulatory expertise.
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Frequently Asked Questions
Is there still any questions from you? You can contact us for more advanced questions or answers
What is ISO 13485 certification?
ISO 13485 certification confirms that an organization meets quality management requirements specific to medical devices.
Is ISO 13485 mandatory in Germany?
ISO 13485 is not legally mandatory but is widely required for medical device market access and regulatory compliance.
How long does ISO 13485 certification take?
Typically 8 to 16 weeks, depending on organization size, product complexity, and readiness.
Do you provide ISO 13485 internal audits?
Yes. We conduct ISO 13485 internal audits and provide full audit preparation support.
What Our Customers Say About Us
Are you still hesitating to use our services? These are the testimonials of our customers.
It was a pleasure to work with Jonathan on my project. He smoothly understood my needs and proactively found appropriate solutions. In discussion with him, I also became aware of pitfalls I hadn’t noticed. I will continue to cooperate on the other projects. I highly recommend Jonathan
Lubos Tichy,
CEO HandsUnity, s.r.o
Lance Tearnan
LTswim
