Comprehensive quality controls along the entire process chain from granulate to finished product and highly trained employees ensure that only safe, compliant products leave our plants. Products manufactured by Röchling Medical are used to prevent, diagnose and cure diseases - we are aware of our responsibility.
We meet our customers specifications and the regulatory requirements for products and processes on the basis of a certified and integrated management system, under the DIN EN ISO 9001, ISO 13485 and ISO 15378 standards.
Our state-of-the-art facilities are highly automated in all process steps, from manufacturing, assembly and quality inspection to transfer and packaging. We are able to engineer production processes that exclude the risk of contamination and ensure stable processes for consistent, reproducible quality.
We systematically qualify our premises, equiment and devices and validate the whole process chain to ensure process-safe manufacturing flows and consistent, reliably reproducible outcomes. Every individual step is monitored and documented to ensure complete transparency and traceability.
In our manufacturing processes, we use 100% inline camera or sensor inspection. Depending on product-specific requirements, we can draw on a wide range of optical and tactile measuring devices and testing equipment for material analyses, functional tests and environmental simulations - as well as an in-house S1 lab.
We advise and support our customers to the full extent with regard to validation. Products for medical technology, pharmaceuticals and diagnostics are subject to strict regulations. Our experts are familiar with the applicable standards and perform validations according to ISO 13485. For this purpose, we create a validation concept tailored to the individual requirements or work according to the customer's specified concept. Many medical device manufacturers are already required to be MDR-compliant or are preparing to do so. Our technical documentation supports them in meeting these requirements.
|ISO 9001||Quality Management Systems – Requirements||—||—||X||X||—||X|
|ISO 15378||Primary packaging materials for medicinal products – Particular requirements for the application of ISO 9001, with reference to good manufacturing practice (GMP)||X||X||—||—||—||—|
|ISO 13485||Medical Devices – Quality management systems – Requirements for regulatory purposes||X||X||X||X||X||X|
|ISO 50001||Energy management systems – Requirements with guidance for use||X||X||X||—||—||—|
|ISO 14001||Environmental management systems – Requirements with guidance for use||X||X||—||—||—||—|
|ISO 45001||Occupational health and safety management system||X||X||—||—||—||—|
|ISO 8317||Child Resistant Packaging – Requirements and testing procedures for reclosable packages||X||—||—||—||—||—|
|ISCC-PLUS||Compliance with the requirements of the certification system ISCC PLUS|
(International Sustainability and Carbon Certification) - certified materials for circular and bio-based packaging solutions
|Drug Master Files||(for selected products)||X||—||—||—||—||—|
GMP refers to guidelines for quality assurance of the production processes and environment in the production of drugs and active pharmaceutical ingredients. EU GMP regulations include requirements for quality systems, premises and equipment, documentation and traceability.
As suppliers to the pharmaceutical industry, the Röchling Medical sites in Brensbach and Neuhaus are certified according to ISO 15378 and produce strictly according to GMP specifications in cleanrooms of GMP class C + D.
With our in-house S1 laboratory, we are able to carry out the complete microbiological monitoring of our production environment ourselves, from sampling to evaluation. This allows us to react quickly and preventively to maintain the required high hygiene standards.
All of our Röchling Medical sites actively live by the principles of GMP. We continuously invest in the expertise and further training of our employees with GMP, safety, hygiene and cleanroom training courses.
As a solution provider, we combine our expertise in research & product development, materials & technologies, and automation & industrialization with our experience, our quality standards, and our ambition to work with our customers to design a product that meets their individual requirements.
Our case studies give you an insight into the challenges faced by our customers in pharma, diagnostics and medical technology sectors and the tailor-made solutions that we jointly created for them.
Our customers benefit from our extensive expertise in plastics and metal processing, but also from our many years of experience in medical technology and pharma. As your solution partner, we are familiar with both the regulatory and practical requirements of creating components and products for the healthcare sector tailored to your needs. We meet the highest quality and hygiene standards and operate in strict compliance with relevant regulations, such as the Medical Device Regulation (MDR).
For more information about quality and regulatory affairs, please contact our team.
We look forward to hearing from you.
Global Director Quality & Regulatory Affairs