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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.

Comprehensive quality controls in the cleanroom
Inline camera and sensor inspection
Quality control of samples in the S-1 laboratory in Neuhaus
Quality inspection by optical measurement with the tactile measuring machine

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

ISO 9001Quality Management Systems – RequirementsXXX
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
Drug Master Files(for selected products)X
 FDA registeredXXXX


"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.

Inline Camera Inspection
Quality inspection with the tactile measuring machines
Quality inspection with the tactile measuring machine
Quality controls along the entire process chain

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 Assembly for a Class 3 Medical Device

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.
Glass Vial Protection

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.
High-Speed automatic assembly solution for medical technology devices

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.
Case Study: Ensuring the Manufacturability of a Complex Functional Design

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.
Quality Controlling of Non-Standing Articles

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

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.
Simulation Product development medical technology

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 Röchling Medical

Roman Borkowski
Chief Quality & Regulatory Officer

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