Documented Responsibility
As a manufacturer of medical devices, we bear responsibility – for patients, users, and partners around the world. Our certifications according to MDR (EU) 2017/745 and DIN EN ISO 13485:2021 confirm that we take this responsibility seriously.
They stand for transparent processes, documented quality, and continuous improvement – ensuring that our customers can rely on every detail.
MDR Certification – Safety and Trust
The European Medical Device Regulation (MDR) defines clear standards for quality, safety, and transparency. Its requirements guide every step – from product development to market surveillance.
Reliably tested products:
The European Medical Device Regulation (MDR) defines clear standards for quality, safety, and transparency. Its requirements guide every step – from product development to market surveillance.
Reliably tested products:
All Sutter products subject to the MDR comply with current EU requirements and meet the essential safety and performance standards.
Compliant market access:
MDR certification ensures that our medical devices are legally approved and can be marketed across Europe without restrictions.
Full traceability throughout the product lifecycle:
A unique device identification (UDI) system guarantees complete traceability of our products from manufacturing to end use.
Future-ready structures:
Our certified processes and quality standards ensure that we meet future regulatory requirements reliably – supporting sustainable healthcare delivery.