After my studies in biology and subsequent doctorate I initially worked as scientific staff for the specialized clinic Neukirchen. From 2000 to 2018 I was employed – lately in senior position – in the adjoined fields of Medical and Regulatory Affairs for medical devices. As of 2011 I have additionally been active as a self-employed medical writer. In October 2018 I quit my employment to dedicate my time fully to own customer projects,

What I love most about my work is that it allows me to unite two of my passions: Science and Language.

My aim is to provide customized support for your valuable project – exactly the way you deserve it!

My plus in expertise:

  • Dr. rer. nat. (PhD) – academically qualified biologist
  • Training as regulatory affairs manager medical devices (Certificate Universität zu Lübeck)
  • Advanced training in marketing and scientific communication
  • Statistics (Certificates Duke University)
  • Data Analyst with R (Datacamp)
  • GCP
  • Healthcare Compliance
  • Languages: German (native), English ( Common european framework of reference level C2), French (B2), Italian (B2), Finnish (A1)

Product groups worked with:

Camera Light Source Systems for endoscopy | Rigid endoscopes for spine surgery | Spinal fusion cages | Radiofrequency probes for electrosurgery | Intramedullary distraction nails | Hip implants | Knee endoprostheses (TKA)| Cement restrictors| Aspiration catheters | Catheters for urology | Cycler for peritoneal dialysis | Sphygmomanometers | Nebulizers (Jet- and vibrating mesh nebulizers, stand-alone, mechanical ventilation) | Devices for respiratory physiotherapy | Holding chambers/spacers for pMDI | Laryngoscopes | Otoscopes | Dermatoscopes | Ophthalmoscopes | Examination Lights | Saline solutions for inhalation| Dental materials | Surgical instruments| Occluders in heart surgery| Viscoelastics for ophthalmology

Indications

Respiratory disorders | Spine disoders | Hip arthroplasty | Hereditary angioedema | Cystic fibrosis | Cystinosis | Leg lengthening | Parts of hemophilia | Some of the autoinflammatory diseases

Succesful Projects

  • Successful clinical evaluations for more than 20 groups of products – among others clinical evaluation plans and reports for class III products according to the requirements of MDR (EU) 2017/745
  • Successful submissions for the reimbursement of drug-like medical products in Germany’s G-BA
  • Support with successful submissions of different medical devices for payors in different countries (Europe, USA, South Africa)
  • Clinical study protocol setup
  • Clinical study reports
  • Creating biocompatibility reports
  • Supporting process development risk management ISO 14971, PMS and clinical evaluation (MDR (EU) 2017/745)
  • Training on fundamentals of evidence based medicine (EBM)

My partners

I believe in teamwork – Teamwork makes the dream work:

Quatedo – Ingenieurbüro Stefan Hüffer

Ursula Loos – Übersetzung, Lektorat, Scientific Writing

MEWICO - Medical Scientific Consulting - Christine Ernst

Cornelia Sauter – Medical Content Verification