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Waldachtal
Certifications - Röchling Medical Waldachtal AG
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EcoVadis Rating for Röchling Medical Waldachtal
Röchling Medical Waldachtal is EcoVadis-rated. 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 Waldachtal ensures compliance with both customer specifications and regulatory requirements for products and processes. The site holds multiple certifications, demonstrating its commitment to quality, safety, and sustainability.
Certifications:
- ISO 13485 – Implementation and maintenance of a Quality Management System for medical devices
- ISO 50001 – Commitment to energy efficiency through an Energy Management System
- ISO 9001 – Quality Management Systems – Requirements
Our Röchling Medical Waldachtal site is FDA-registered, as are our U.S. sites and the German Brensbach site.
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 Waldachtal, please feel free to contact us.
We look forward to hearing from you.
Thierry Arnaud
Vice President - Sales & Marketing Europe
Hendrik Liebau
Site Director
