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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

CertificationAreaNeuhaus
Germany		Brensbach
Germany		Waldachtal
Germany		Rochester
USA		Lancaster
USA		Suzhou
China
ISO 9001Quality Management Systems – Requirements——XX—X
ISO 15378Primary packaging materials for medicinal products – Particular requirements for the application of ISO 9001, with reference to good manufacturing practice (GMP)XX————
ISO 13485Medical Devices – Quality management systems – Requirements for regulatory purposesXXXXXX
ISO 50001Energy management systems – Requirements with guidance for useXXX———
ISO 14001Environmental management systems – Requirements with guidance for useXX————
ISO 45001Occupational health and safety management systemXX————
ISO 8317Child Resistant Packaging – Requirements and testing procedures for reclosable packagesX—————
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		XXX———
Drug Master Files(for selected products)X—————
 FDA registered—XXXX—

 

Download Certificates

"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

Brensbach

Lancaster

Rochester

Neuhaus am Rennweg

Waldachtal

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 for them.

Patient-Centric Pharmaceutical Packaging Design

Case study demonstrating how Röchling Medical integrates the patient’s perspective in the product design process.
Discover Case Study

Optimizing a Complex Class 3 Medical Device

Case study showing how Röchling Medical uses intelligent product redesign to simplify manufacturing processes, automate assembly procedures, and optimize product features.
Discover Case Study

Innovative Plastic Protectors for Glass Injection Vials

Case study describing how Röchling Medical took Design for Manufacturing to a new level in developing a smart packaging solution to safeguard toxic or expensive drugs.
Discover Case Study

Custom Automation Concepts

Case study detailing Röchling Medical´s solution for advanced tooling and automation concepts in combining injection molding and assembling.
Discover Case Study

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.
Discover Case Study

Automated Quality Control

Case study showing how Röchling Medical solved in-line quality control challenges by developing an intelligent automation solution. 
Discover Case Study

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).

Your Innovative Development Partner

From idea to end product, we are your development partner for complex medical devices and custom solutions.

Discover Product Design & Development

Expertise in Plastic and Metal Processing

We combine our deep material expertise with a wide range of process technologies for individual manufacturing concepts.

Discover Technologies & Materials

Customized Manufacturing Solutions

Smart, tailored cleanroom automation concepts for ultra-clean production and economic serialization.

Discover Automation Engineering

Precision Molding Tools for Exceptional Quality

Our inhouse tool making, maintenance and repair service ensures high flexibility and short response times.

Discover Mold Making

Individual Cleanroom Assembly and Finishing Concepts

Fully automated or manual – we develop the optimal assembly and post-processing solution for your project.

Discover Assembly & Post-Processing

Inhouse Packaging Development and Sterilization Coordination

We fulfill your requirements for sterilized or sterile products, optimally protected by tailor-made packaging.

Discover Packaging & Sterilization

Our Sites Are Certified for the Best Quality

We offer quality assurance concepts and regulatory support tailored to product-specific requirements.

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Contact Us

For more information about quality and regulatory affairs, please contact our team.

We look forward to hearing from you.

Grit Pasche
Global Director Quality & Regulatory Affairs

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