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CEHTRA - Consultancy for Environmental & Human Toxicology and Risk AssessmentMedical Devices : Cehtra Service
regulatory complianceregulatory servicesRegulatory affairs consultantbiocides, consultant, toxicologist, risk assessmentREACH, consultant, toxicologist, risk assessment
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Medical Devices

Medical Devices : Cehtra Service For your Medical Devices: a strong and complete Biological Evaluation

Serenity in the Regulatory Affairs Department: as a provider independent from CROs, CEHTRA can manage the entire risk analysis process including physico-chemical and toxicological study monitoring, as well as the formalisation of the final biological evaluation report, as illustrated in the chart below:

 

CEHTRA can provide support at every stage of this process, or just individual steps, including the Biological Evaluation Report by an ERT toxicologist.

CEHTRA is recognized for the strong dossiers we provide as we strive for quality in our service.

 

According to the ISO 10 993 standard (part 1 to 20), Medical Devices have to comply to new requirements related to Biological Medical Devices Assesment – a field where CEHTRA’s Toxicological Expertise and Expertise in Material Sciences will prove invaluable, especially for the risk analysis of Medical Devices:

  • Physical & Chemical characterisation of Medical Devices
  • Physical & Chemical characterisation of packaging materials

CEHTRA is a consultancy specialised in chemical safety regulation. We are active in many markets such as chemical substances (REACH), biocides, cosmetics and their packaging, food & feed, food contact materials, pharmaceutical products and medical devices.

 
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®Cehtra • October 2017