Biological safety evaluation of medical devices is a part of regulatory requirement. The scope of the webinar is to understand the strategy behind the biocompatibility testing and a step wise approach to implement biocompatibility requirements. The topics covered are as follows: Biocompatibility strategy Role of material characterization Biocompatibility studies and Toxicology risk assessment Register to... read more
Medical devices delivered in a sterile state must be designed, manufactured, and packed to ensure they are sterile when placed on the market. However, device packaging can degrade over time or become compromised during packing, transportation, distribution, storage or handling. Many device regulators require medical device shelf-life and package testing to the ISO 11607 series... read more
The clinical evaluation is an essential part of the technical documentation, which manufacturers are required to use to document their compliance with the general safety and performance requirements. The new medical Device Regulations places greater emphasis on the use of clinical data to demonstrate compliance with the general safety and performance requirements. And for certain... read more
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