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Designation under IVDR (EU) 2017/746More
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Opening of Israel Branch Office in HaifaMore
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MDR – EU Commission asks manufacturers for applicationsMore
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Recognition in TaiwanMore
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10th December 1996 - 10th December 2021More
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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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