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Certifications

Certifications

The consistent implementation of a certified quality management system in line with both pharmaceutical requirements, which are closely linked to compliance with GMP guidelines for good manufacturing practice, and regulatory requirements for medical devices, means that we can guarantee our processes are always being carried out under controlled and reproducible conditions.

Röchling Medical has numerous certificates for management systems and products and is constantly working on new developments and their associated certification.

All of our actions are marked by a distinct focus on sustainability. This includes a profound awareness of environmental and energy related matters portrayed by the implementation of certified management systems that comply with ISO 14001 – Environmental management and ISO 50001 – Energy management. It goes without saying that we actively comply with health and safety at work requirements.

Strictly controlled environmental conditions are required in the manufacture of products for the pharmaceutical, life science and diagnostics sectors. All our locations are able to produce items in cleanroom conditions.

The following table gives on overview of our locations and their certifications:

CertificationAreaNeuhaus
Germany
Brensbach
Germany
Waldachtal
Germany
Rochester
USA
Lancaster
USA
Suzhou
China
ISO 9001Quality Management Systems – RequirementsXXXX
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

IATF 16949

Quality management system requirements for automotive production and relevant service parts organisationsXX
ISO 50001Energy management systems – Requirements with guidance for useXXX
ISO 14001Environmental management systems – Requirements with guidance for useXX
ISO 8317Child Resistant Packaging – Requirements and testing procedures for reclosable packagesXX
Drug Master Files(for selected products)XX
 FDA registeredXXX

 

Documents: Certifications and Approvals

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System solutions and components for Diagnostics, Fluid Management, Pharma and Surgery

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