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  • Designation under IVDR (EU) 2017/746
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  • Opening of Israel Branch Office in Haifa
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  • MDR – EU Commission asks manufacturers for applications
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  • Recognition in Taiwan
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  • 10th December 1996 - 10th December 2021
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  • 2021-05-26: Start of application of the new Medical Device Regulation

    As of 2021-05-26, the Medical Device Directive 93/42/EEC (MDD) and the Active Implantable Medical Device Directive 90/385/EEC (AIMDD) are history.

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  • Brexit and its implications for CE marking of medical devices and in vitro diagnostics

    A very eventful year lies behind us. The Corona pandemic had a massive impact on all areas of life and is still not over yet.

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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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