Evidence-based. Systematic. Compliant.
You need a clinical evaluation in compliance with MDR (EU) 2017/745 for the technical documentation of your innovative medical device? Or a study protocol as per MDR / ISO 14155? Or a systematic and reliably documented literature research for another purpose? For example, a reimbursement application? Or the assessment of the biocompatibility?
Use the plus in expertise!
- Certified training as regulatory affairs manager medical devices (Universität zu Lübeck)
- Longstanding industry experience in the subject areas Medical Affairs/ Regulatory Affairs
- Certified training in statistics (Duke University)
- Successful clinical evaluations in compliance with the up-to-date MEDDEV 2.7/1 for more than 20 groups of products and first 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
- Creating biocompatibility reports
Product Groups worked with
Camera Light Source Systems for endoscopy | Rigid endoscopes for spine surgery | Spinal fusion cages | Spinal disc replacements | 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 | pMDIs | DPIs | Laryngoscopes | Otoscopes | Dermatoscopes | Ophthalmoscopes | Examination Lights | Saline solutions for inhalation| Dental materials | Surgical instruments | Heat pads
Texts can be created in both German or English.
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