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Quality & Regulatory
Excellence in Quality for Patient Safety
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.
Integrated Quality Management System
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.
State-of-the-Art, Automated Facilities
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.
Reliably 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.
High-Standard Testing and Inspection Equipment
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.
Regulatory Support
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.
Our Certifications
| Certification | Area | Neuhaus Germany | Brensbach Germany | Waldachtal Germany | Rochester USA | Lancaster USA | Suzhou China |
| 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 | X | — | X | — | — | — |
| Drug Master Files | (for selected products) | X | — | — | — | — | — |
| FDA registered | — | X | X | X | X | — |
"Good Manufacturing Practice" (GMP)
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.
Competences at Our Locations
Case Studies
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 with them.
Patient-Centric Pharmaceutical Packaging Design
Röchling Medical collaborated with Heidelberg University Hospital to develop optimised packaging designs for and together with patients with motor impairments.
Optimizing a Complex Class 3 Medical Device
By intelligent product redesign, we are able to simplify manufacturing processes, automate assembly procedures and optimize product features.
Innovative Plastic Protectors for Glass Injection Vials
The damage caused by glass breakage is particularly high for expensive or toxic injectables. Röchling Medical developed a smart packaging solution to safeguard those drugs.
Custom Automation Concepts
With our experience and know-how in combining injection molding and assembly, we find intelligent solutions for advanced tooling and automation concepts.
Design for Manufacturability
Challenged to optimise design for manufacturability, Röchling Medical combined three processing technologies for a multi-component container system for use in diagnostic analyzers.
Automated Quality Control
Find out how we solved in-line quality control challenges for containers with peaked bottoms by developing an intelligent automation solution.
Metal and Plastic Processing from a Single Source
To produce a trocar for ophthalmic surgery, Röchling Medical Lancaster combines its expertise in metal processing and injection molding and supplies the instrument as a complete, ready-to-use kit from a single source.
Medical Device Contract Manufacturing
For a complex surgical instrument, Röchling Medical Lancaster is providing full-service contract manufacturing of cleanroom molded parts, supply chain handling of subcomponents, precision assembly and packaging.
A Single Use Medical Device Designed for Sustainability
Röchling Medical applied the principles of Design-for-Sustainability (DfS) to the development of a standard plastic trocar and significantly improved the carbon footprint of the disposable medical product.
Simulations in Product Development
By performing simulations in the product development process of a housing system for an electronic medical device used for life-saving treatments, we were able to save considerable costs and time for our customer.
Röchling Medical Competences
Our Expertise, Your Benefit
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).
Contact Us
For more information about quality and regulatory affairs, please contact our team.
We look forward to hearing from you.
Roman Borkowski
Chief Quality & Regulatory Officer
