Set the sails. There are...

tailor-made solutions for you

Regulatory Medical Writing

Reimbursement dossiers for medical devices, clinical evaluation MDR (EU) 2017/745, clinical investigation plans and reports ISO 14155 / MDR (EU) 2017/745

Scientific Medical Writing

Original publications, abstracts, book chapters, minute-taking at Medical Advisory Boards, conference reports.

Clinical Evidence

Training fundamentals of clinical evidence (study designs, short glimpse on statistics, risk of bias etc.), data analysis and visualisation.

QM Processes

Supporting implementation of risk management ISO 14971, PMS or clinical evaluation processes (MDR (EU) 2017/745)

Qualification and Expertise

Continuing Education

  • Dr. rer. nat. (PhD) – academically qualified biologist
  • Training as regulatory affairs manager medical devices (Certificate Universität zu Lübeck)
  • Training in scientific communication
  • Statistics (Certificates Duke University)
  • Data Analyst with R (Certificate Datacamp)
  • GCP (Certificate Citiprogram)
  • Healthcare Compliance (Certificate AKG)

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 | Knee arthroplasty | Hereditary angioedema | Cystic fibrosis | Cystinosis | Leg lengthening | Parts of hemophilia | Some of the autoinflammatory diseases

You have come to the right place

Use my expertise: starting with my professional communication through to my scientific method of working right up to my advanced understanding of regulatory requirements. My aim is to provide customized support for your valuable project – exactly the way you deserve it!

in numbers

22
years of experience
196
successful projects
100
percent fair prices