Grieshaber receives certification according to DIN EN ISO 13485:2016
The quality requirements for the handling of medical devices are increasing significantly. This is mainly a result of the revised legislation that has become valid with the Medical Device Regulation (MDR) (EU) 2017/745 since 25.05.2021. Many manufacturers and distributors of medical devices will face new challenges.
The ISO 13485 standard specifies the requirements for a quality management system of an organisation providing medical devices as well as related services. It addresses requirements for regulatory purposes towards the manufacturer and provider of medical devices in the areas of development, implementation and maintenance of the management systems.
However, all questions regarding the implementation of the new EU regulation have not yet been answered in their entirety.
Grieshaber Logistics Group AG looks back on many years of experience in pharmaceutical logistics and has established a best-in-class quality management system. Thus, Grieshaber was well prepared and fulfils the requirements of the quality standard DIN EN ISO 13485 for medical devices, which are set in the context of the revision of the EU regulation.
In November 2021, the Hochrhein Logistics Park in Rheinfelden was also included in the certification in addition to the already certified locations in Biebesheim. The mdc (medical device certification) body, accredited by the DAkkS and designated in accordance with Regulations (EU) 2017/745 and (EU) 2017/746, carried out the certification. Not a single minor deviation was issued. The quality management system of Grieshaber Logistics Group AG was expressly praised and is to be continued in this form.
With this certification, Grieshaber has once again succeeded in meeting the high requirements of the medical sector and thus in continuing to offer high-quality and value-added services along the complex supply chain of the HealthCare division.
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