By using our extensive network of raw material suppliers, SAXOCON can help obtain relevant information regarding physical, chemical and biological properties from the chain of supply for device construction materials. Based on this and our excellence in manufacturing processes and treatment steps involved in the production of medical devices, we assist our clients in putting together an appropriate biological evaluation plan of the device as required by ISO 10993-1. The biological evaluation plan will contain all the arrangements and responsibilities for filling out the gaps in information needed to conclude on the biological safety of the device including additional biological tests and chemical analysis of extractable and leachable substances.
After accomplishment of the plan, materials of construction and intended use we combine all available data and information relevant to the product clinical data and post-market surveillance data (if any) in order to provide a comprehensive biological risk assessment of product safety and mitigate any risks identified. The result of this will documented as a Biological Evaluation Report. By feeding back to the overall product risk management according to ISO 14971, we also act as a partner in risk control by providing sound scientific rationale and justification for any recommendations or conclusions concerning acceptability of any risks and ensure a high level of safety for patients and users.