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Rochester
Certifications - Röchling Medical Rochester
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EcoVadis Rating for Röchling Medical Rochester
Röchling Medical Rochester is EcoVadis-rated and holds the Bronze Medal.
All Röchling Medical sites in Germany and the United States are EcoVadis-rated. We regularly assess our performance and identify opportunities for improvement, with a focus on environmental responsibility, labor and human rights, ethics, and sustainable procurement.
Certifications & Compliance
Röchling Medical Rochester ensures compliance with both customer specifications and regulatory requirements for products and processes. The site holds ISO 13485 certification for establishing and maintaining a quality management system that meets regulatory requirements for medical devices and ISO 27001 for implementing and maintaining an Information Security Management System.
Certifications:
- ISO 13485 – Implementation and maintenance of a Quality Management System for medical devices
- ISO 27001 – Implementation and maintenance of a an Information Security Management System
Our Röchling Medical Rochester site is FDA-registered, as are our second U.S. site, Lancaster, and the German sites Waldachtal and Brensbach.
Regulatory Support
Röchling Medical provides expert regulatory support, assisting customers with validation processes. Medical technology, pharmaceutical, and diagnostic products are subject to strict regulations, and Röchling Medical’s specialists are well-versed in industry standards.
Our services include:
- Validation processes in accordance with ISO 13485
- Tailored validation concepts for specific requirements
- Compliance with customer-specified concepts
- Support for medical device manufacturers transitioning to MDR compliance
Our expertise ensures that customers meet all regulatory requirements efficiently and seamlessly.
Contact Us
If you have any questions about our competence center in Rochester, please feel free to contact us.
We look forward to hearing from you.
Bill Ruth
Vice President - Sales & Marketing
Sherry Gray
Site Director
