Clinical-scientific support

Maßgeschneiderte Lösungen

Unsere Umsetzungsmodule decken alle typischen Fragestellungen von Herstellern ab von der strategischen Ausrichtung über Personalentwicklung bis hin zu Prozess- und Qualitätsoptimierungsmodulen.

Manufacturer's support from A-Z

Manufacturer's support from A-Z

The entire development period of a medical device, which lasts on average more than 4 years, includes ...

Counseling the product idea

Counseling the product idea

The question of redeveloping a product based on an idea touches on equally profound strategic, operational and economic ...

Patenting

Patenting

Intellectual properties often have to be secured by means of patents and can be used at the interface of technology and medicine medical writing ...

Classification

Classification

Impact of Classification on Manufacturer's Expenditure Classification has a significant impact on the necessity and extent of any clinically required disease.

Preclinical tests

Preclinical tests

The planning and execution of a substantial part of the preclinical tests of the future medical device will naturally depend on the late ...

Scrutiny method

Scrutiny method

The new Scrutiny procedure focuses on the regulatory review of the submitted clinical evaluation by the European Commission. For this the notified...

Conformity procedures

Conformity procedures

The market approval takes place by means of conformity assessment procedures with the following CE marking. After the new EU MDR, the Clinical application...

Risk management

Risk management

The clinical evaluation has a special impact on risk management The results of the clinical evaluation have a significant impact on risk management. Only the clinical evaluation can ...

G-BA/NUB procedure

G-BA/NUB procedure

In the outpatient area, a reservation of authorization applies to the distribution of medical devices at the expense of the statutory health insurance. You may only after a positive decision of the ...

Management consulting

Management consulting

Specialists with completed additional training in Business Administration (MBA) or international professional experience in global consulting Firms offer at the interface of medicine and business management ...

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