Ensure Medical Device Success with ISO 13485 Consulting
Establish a robust quality management system that not only meets regulatory requirements, but also makes your company stand out in the medical device market. Discover how to take quality assurance to the next level with our expert advice for ISO 13485 certification.
- Sustainable support guaranteed
- Expert for quality management
- Fast implementation in your company
The Path to ISO 13485
Global recognition
Global recognition, increased operational efficiency, expanded market access.
Individual advice
Tailored advice, detailed instructions, audit support, post-certification assistance.
Extensive QM resources
Extensive QM resources, continuous improvement support.
Expert ISO 13485 Consulting for Medical Device Manufacturers
Sternberg Consulting is built on a foundation of practical experience, in-depth industry knowledge and a commitment to personalized service. Our journey began when we recognized the gap in bespoke, expert advice for ISO certification in the medical device sector. Our team is made up of experienced professionals who not only have first-hand knowledge of obtaining and maintaining ISO certifications, but are also passionate about passing them on to empower others.
Individual Steps of Our Consulting
Depending on the wishes and needs of our customers, we usually carry out the sqm consultation in the following steps.
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Defining the Scope of Services:
Define the scope and prepare funding applications: Decide whether to implement a new quality management system or adapt an existing one. Review and apply for potential BAFA funding.
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Capture Scope of Services & Current State
Before signing the contract, we clearly define the scope of our services. We then capture the current state of company processes and documentation to identify existing processes and the implementation of quality management measures.
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Identify Measures & Ensure Compliance
We determine the necessary measures, strategies, and processes to ensure compliance with standards on an ongoing basis.
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Process Documentation & Certification Preparation
Document the processes and relevant evidence, such as quality objectives and management review, to optimally prepare for certification.
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Interne Audits durchführen
We conduct internal audits to review and ensure compliance with established quality standards and processes.
Achieve Excellence with ISO 13485 Consulting
In the rapidly evolving medical device industry, maintaining a state-of-the-art quality management system (QMS) is not just an option, it’s a necessity. Many companies struggle with the complexity of ISO 13485 certification and face challenges such as a lack of internal expertise, resource constraints and the continuous development of regulatory standards. Sternberg Consulting knows these challenges inside out and is here to guide you every step of the way, turning obstacles into milestones on the road to operational excellence.
Set New Quality Benchmarks
with ISO 13485
Imagine a future in which your company not only meets international standards, but also sets new benchmarks for quality. With ISO 13485 certification, you open doors to global markets, improve product quality and significantly increase the trust and satisfaction of your customers. Sternberg Consulting is your partner on this path and provides individual advice for long-term success and independence in quality management.
Funding Opportunities 🇩🇪
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!
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
Excellent work. I will highly recommend this individual.
Lance Tearnan
LTswim
Frequently Asked Questions
Is there still any questions from you? You can contact us for more advanced questions or answers
What are the benefits of ISO 9001 certification?
Benefits include improved efficiency, increased customer satisfaction, enhanced reputation, better decision-making, and access to new markets.
