Publications

Company

• HPZenner Clinical company profilePDF ↓
• HPZenner Clinical service cataloguePDF ↓

Papers

• PMS/PMCF — obtaining clinical data of CE-marked devices under MDR (German)extern ↗
• MDR-compliant clinical evaluation of medical devices (German)PDF ↓
• MDR-compliant clinical evaluation of software incl. DiGA (German)extern ↗
• Clinical studies and clinical trials (March 2021, German)PDF ↓
• Practical experience with clinical evaluation (German)PDF ↓
• Market and management analysis: overcoming the MDR disruptionextern ↗
• Fast track into the BfArM DiGA directory (German)PDF ↓

Scientific publications

Our clinical evaluators are authors or co-authors of the following scientific publications, and contribute to publications of national academies and international commissions.

• PUBMED database: original papers on medical device R&Dextern ↗
• Molecular personalized medicine for medical devices (Springer-Nature)PDF ↓
• Individualised medicine through medical technology (ACATECH)extern ↗
• Personalized Medicine (Springer-Nature)PDF ↓
• Clinical Evaluation of Medical Devices (Springer-Nature)PDF ↓
• Environmental Noise (WHO)PDF ↓
• Contamination risks of medical devices (Springer-Nature)PDF ↓
• Decontamination of medical devices (Springer-Nature)PDF ↓

Flyers

• MDR requirements for stand-alone software (German)PDF ↓
• MDR requirements for clinical evaluators (German)PDF ↓
• Clinical trials (for MedicalMountains)extern ↗
• DiGA reimbursement approval at BfArM (German)PDF ↓