STRONGER TOGETHER
STRONGER TOGETHER
ENSURE THE SUCCESS OF YOUR MEDICAL DEVICES WITH ISO 13485 – AN ESSENTIAL STEP FOR MANUFACTURERS AND AN OPPORTUNITY FOR SUPPLIERS.
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.
STRONGER TOGETHER
STRONGER TOGETHER
ENSURE THE SUCCESS OF YOUR MEDICAL DEVICES WITH ISO 13485 – AN ESSENTIAL STEP FOR MANUFACTURERS AND AN OPPORTUNITY FOR SUPPLIERS.
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.
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.
ISO 13485: The key to building trust and expanding the market in the medical device industry
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.
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.
ISO 13485: The key to building trust and expanding the market in the medical device industry
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.
Our solution is based on a deep understanding of the unique requirements of the medical device manufacturing industry
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.
Our solution is based on a deep understanding of the unique requirements of the medical device manufacturing industry
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.
ISO 13485 certification consulting: customized guidance for medical device manufacturers
Our consulting services are designed to ease your path to ISO 13485 certification and provide you with the knowledge and tools for a robust and sustainable QMS. We offer:
Bonus:
A comprehensive guide to maintaining your ISO certification.
Contact us for a customized offer tailored to your specific needs and objectives.
ISO 13485 certification consulting: customized guidance for medical device manufacturers
Our consulting services are designed to ease your path to ISO 13485 certification and provide you with the knowledge and tools for a robust and sustainable QMS. We offer:
Bonus:
A comprehensive guide to maintaining your ISO certification.
Contact us for a customized offer tailored to your specific needs and objectives.
Tailor-made for your needs:
This is the right course for you if you are entering the medical device manufacturing sector and are aiming for ISO 13485 certification or if you want to expand your market potential as a supplier to medical device manufacturers.
If you want to master the complexity of ISO 13485 certification with a trustworthy partner at your side, Sternberg Consulting is the ideal choice.
Tailor-made for your needs:
This is the right course for you if you are entering the medical device manufacturing sector and are aiming for ISO 13485 certification or if you want to expand your market potential as a supplier to medical device manufacturers.
If you want to master the complexity of ISO 13485 certification with a trustworthy partner at your side, Sternberg Consulting is the ideal choice.
Other services
Internal audit
An internal audit ensures your quality management, efficiency and ISO 9001 conformity. We identify your weak points, offer customized solutions and thus promote quality, customer satisfaction and company strengthening.
External quality management
Interim Management Service
Our interim management service provides rapid expert support for quality management tasks by providing a specialist consultant to lead your quality management consultancy’s initiatives when required.
Other services
Internal audit
An internal audit ensures your quality management, efficiency and ISO 9001 conformity. We identify your weak points, offer customized solutions and thus promote quality, customer satisfaction and company strengthening.
External quality management
Interim Management Service
Our interim management service provides rapid expert support for quality management tasks by providing a specialist consultant to lead your quality management consultancy’s initiatives when required.
QM Blog: Your knowledge advantage
Welcome to our QM blog – the hub for the latest ISO 9001 insights. Stay up to date on standards, optimization advice and industry trends. With Sternberg Consulting you always stay one step ahead.
QM Blog: Your knowledge advantage
Welcome to our QM blog – the hub for the latest ISO 9001 insights. Stay up to date on standards, optimization advice and industry trends. With Sternberg Consulting you always stay one step ahead.
Yes, ISO 13485 is basically mandatory for manufacturers of medical devices and in vitro diagnostic devices in the European Union (EU). While it’s not explicitly mandated by EU regulations, compliance with ISO 13485 is harmonized with the requirements of the Medical Device Regulation (MDR) and In-vitro Diagnostic Regulation (IVDR). Achieving compliance with this standard enables organizations to establish a comprehensive Quality Management System (QMS) that aligns with the demands of MDR and IVDR. This, in turn, allows them to obtain the CE marking, which is obligatory for medical device market access within the EU. Therefore, while not directly mandated, adherence to ISO 13485 is practically essential for manufacturers seeking to operate within the EU market.
Yes, ISO 13485 is primarily intended for organizations in the medical device industry (including suppliers) to ensure the safety and efficacy of medical devices throughout their lifecycle.
ISO 13485 is a standalone standard, separate from ISO 9001. But ISO 9001 is a subset of ISO 13485. So if you comply with ISO 13485, you also comply with ISO 9001.
