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Röchling Medical
Certificates
Current certificates for all Röchling Medical sites for download
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Brochures
Product brochures, flyers and other documents
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Terms and Conditions
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Röchling Medical Certificates
Based on a certified and integrated management system in accordance with DIN EN ISO 9001, ISO 13485, and ISO 15378, we ensure compliance with both customer requirements and regulatory standards for products and processes.
In addition, Röchling Medical holds site-specific certificates, including energy management systems certified to ISO 50001, environmental management systems in accordance with ISO 14001 and the occupational health and safety management system in accordance with ISO 45001. Röchling Medical is also certified to ISCC Plus on a site-specific basis. For selected products, we maintain Drug Master Files and FDA registration for specific sites.
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 expertise ensures that customers meet all regulatory requirements efficiently and seamlessly.
Your Contacts in Europe
Thierry Arnaud
Vice President - Sales & Marketing Europe
Your Contact in the US
Bill Ruth
Vice President - Sales & Marketing
