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Medical Devices - A strong and complete Biological Evaluation

05/10/2017
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 is recognized for the strong dossiers we provide as we strive for quality in our service:

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

 
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 • February 2018