Our products are used in vital and life-changing medical procedures and therefore need to meet the highest quality standards.

We ensure that our products meet the desired standards by subjecting them to ongoing review and optimisation. Our quality management system and products comply with the most stringent regulatory requirements for medical device manufacturers and are regularly audited and certified by national and international authorities and regulatory bodies.

Designed, developed and made in Germany

Promise of quality

We develop, manufacture and supply our customers only with products and services that meet their requirements. These include compliance with high safety and quality standards, fitness for purpose and reliability. By designing efficient processes and a working environment that ensures continuous improvement and independent action, we meet this requirement in all areas of the company.

We are efficient
As a manufacturer and service partner of medical devices we maintain an efficient quality management system that enables us to ensure high delivery capability in compliance with regional, national and international regulations and standards in our target markets. Our proactive quality policy also ensures compliance with requirements and the meeting of the expectations of our customers and interested parties. This allows us to also ensure the long-term profitability of our organisation.

We act collectively
Each individual employee contributes to ensuring our quality standards through their own personal performance. Regular reviews and improvements in the effectiveness of the quality management system by senior management, the quality management officer and the department heads ensure that our mission is accomplished.

The key to top quality
We are constantly improving in everything we do and appreciate the value of long-standing relationships with employees and suppliers. High educational standards of our employees, their ongoing further training and their commitment are fundamental building blocks of our quality promise.

We take responsibility
We protect our environment and the health of our employees sustainably through the careful use of our resources and we promote health and safety at work. On our own initiative, we take preventive measures and assume responsibility for what we do.

We are innovative and customer-oriented
Proactive identification of our customers’ needs and expectations enables ongoing innovation in all our areas. This is the foundation for continual development and our success.

Certifications

The Stockert GmbH quality management system and especially the accompanying handbook are based on and include the consideration and implementation of guidelines and definitions taken from the following standards:

DIN EN ISO 13485 Quality Assurance Systems – Medical Devices Requirements for regulatory purposes
Regulation (EU) 2017/745 Class I medical devices
93/42/EEC Annex II excluding Section 4 – EC Declaration of Conformity (Full QA System)
MDSAP Medical Device Single Audit Program
FDA Regulation Quality System 21CFR Part 820 Quality Systems Regulation

DIN EN ISO 13485

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MDSAP​​​​​​​

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