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Regulatory and legal affairs
At Sysmex, we are subject to a vast number of laws, rules, regulations and standards.
The main focus of our Regulatory Affairs department is to ensure product safety through safe design and protective measures. In addition, we deliver appropriate warnings to our customers through our labelling on instruments, software, reagents, controls and calibrators. Finally, there’s our workers’ safety and our environmental rules and efforts.
We’re not going to continue to be as successful as we are if we do not deliver excellent product quality. Combined with reliable results in the in-vitro diagnostic field, quality is a clear-cut prerequisite for our success. Quality in itself contributes to the safety of a product.
Participation in associations like EDMA and VDGH ensure we are up to date with the latest developments in standardisation, labelling, quality, environmental and electrical issues in so far as they apply to our products.
We comply with export laws and security trade control.
Legal Affairs deals with contracts with our business partners to ensure fruitful, successful, long-term and balanced cooperation. We take into account all aspects of anti-trust and anti-corruption principles at all times.
Data protection is an internal focus of Legal Affairs. In a growing information society, with all its technical possibilities for exchanging data, we need to look after personal patient data with extraordinary care. This is ensured by contract, safe technologies and authorised access.
Registration inside our business area is a prerequisite for our sales – and this is another area of responsibility for the Regulatory Affairs team. Registration of chemicals with the European authority at ECHA is also observed and granted.