Clinical Evaluations



Our services include support for your clinical evaluation reports (CERs) as well as survices for the post-market phase of your medical devices.


Based on your needs this includes

  • Development of Clinical Evaluation Plans (CEPs)
  • CERs for class I to class III devices (EU MDR, FDA, UK MDR)
  • Gap assessment of previous CEPs and CERs
  • Consultancy on MDR compliance
  • PMS reports and PSURs
  • PMCF plans and reports

contact

Biological Evaluations



We are providing you with objective and independent services to establish the biocompatibility of your medical devices.


This includes

  • Writing of Biological Evaluation Plans and Reports (BEP/BER) according to the ISO 10993 series
  • Toxicological risk assessment according to ISO 10993-17
  • Identification and evaluation of hazard, exposure and risk
  • Critical appraisal of toxicology information on health impacts
  • Development of toxicological profiles

contact

have a project in mind?


LET'S TALK.

CB KALO consulting

CVR 39057859



E-MAIL: info@cb-kalo.dk