Certifications & Compliance

Röchling Medical Brensbach 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 14001 – Establishment and upkeep of an Environmental Management System for sustainable operations
• ISO 15378 – Implementation and maintenance of a Quality Management System for primary packaging materials for medicinal products – particular requirements for the application of ISO 9001:2015, with reference to Good Manufacturing Practice (GMP)
• ISO 45001 – Occupational Health and Safety Management System ensuring a safe working environment
• ISO 50001 – Commitment to energy efficiency through an Energy Management System

Our Röchling Medical Brensbach site is FDA-registered, as are our U.S. sites and the German Waldachtal site.

Good Manufacturing Practice (GMP)

GMP outlines essential quality assurance measures for production processes and environments in pharmaceutical and active ingredient manufacturing. The EU GMP regulations define strict criteria for:

• Quality systems
• Premises and equipment
• Documentation and traceability

The Röchling Medical sites in Brensbach and Neuhaus hold ISO 15378 certification, ensuring strict adherence to GMP guidelines in cleanrooms classified as C and D. These controlled environments are essential for maintaining reliably reproducible product quality and regulatory compliance.

All Röchling Medical sites consistently uphold the principles of GMP. Commitment to GMP principles extends to continuous employee education. Röchling Medical invests in specialized training programs covering GMP, safety, hygiene and cleanroom training courses.

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.