Evidence-based. Systematic. Compliant.

You need a clinical evaluation in compliance with MEDDEV 2.7/1 for the technical documentation of your innovative medical device? Or a study protocol as per 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 Projects

  • Successful clinical evaluations in compliance with the up-to-date MEDDEV 2.7/1 for more than 20 groups of products
  • 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 | 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

Texts can be created in both German or English.

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