Clinical-Scientific Support

Tailor-made solutions for manufacturers — from product idea to publication.

Tailor-made solutions

Our implementation modules

Our implementation modules cover all typical questions manufacturers face — from strategic direction through personnel development to process and quality optimisation.

Counselling on your product idea

Strategic, operational and economic advice on developing a new product from an idea.

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Medical Counselling & Scientific Advice

Scientific and medical advice for your development project.

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Clinical Support

Clinical support throughout your device’s entire development period by Prof. Zenner and partners.

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Clinical Writing

Procedure-compliant documents for your conformity assessment.

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CER hands-on training

Anchor the know-how of writing MDR-compliant CERs reliably within your company.

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CER module sharing

Modules-on-demand (MOD) — even more affordable when several manufacturers share similar modules.

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G-BA/NUB procedures

Reimbursement in the outpatient sector: we support your procedure before the G-BA.

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Manufacturer support from A to Z

Support across the entire development period of your medical device — more than 4 years on average.

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Classification

Regulatory classification of your medical device.

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Risk management

Risk management for medical devices.

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Preclinical testing

Planning and appraisal of preclinical investigations.

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Clinical publication of your data

Publication of your clinical data in scientific journals.

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Talk to us

We are happy to advise you on your project.