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Designation under MDR
On 25 April 2020 our designation under Regulation (EU) 2017/745 was published in the official European database NANDO
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Conformity assessment procedures according to Directive 93/42/EEC
For legal manufacturers of medical devices we offer conformity assessment procedures according to Directive 93/42/EEC as a Notified Body.
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Conformity assessment procedures according to Directive 98/79/EC
For legal manufacturers of in vitro diagnostic devices we offer conformity assessment procedures according to Directive 98/79/EC as a Notified Body.
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QM-System Certification
We offer certification according to ISO 13485 and ISO 9001 in the area of medical devices, in vitro diagnostic devices, pharmaceuticals and related areas.
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With Responsibility for Quality and Safety
“Make use of our competence for your certification and CE marking …”
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Highest Quality in Sensitive Areas
“We are your partner on the track to the certificate and CE mark …”
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Pharmaceuticals

Quality Creates Confidence
“Reliable services for reliable products …”
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Quality Management in Health Care Supply
“Our competence for your success …”
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Best Services with Quality
“Quality Management for the Health of Patients …”
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