DHI Environment and Toxicology provides consultancy on health and environmental aspects of the development, manufacturing and marketing of medical devices. DHI can assist in clarifying which standards and regulatory demands apply to specific raw materials and products in various markets. In this way we help you in optimizing the handling and documentation of safety aspects of the products and to comply with the legislative requirements for the registration of medical devices.
Experts in ISO 10993
Our area of expertise covers the preparation of safety assessments of all types of medical devices in accordance with the ISO standardization 10993. We perform biological evaluations of whole devices, parts of devices as well as materials and individual substances. We can also assist you in setting up relevant exposure scenarios for medical devices to calculate the total daily dose and Margin of Safety for critical substances.
• Safety assessments in accordance with ISO 10993
• Selection of biological tests in accordance with ISO 10993
• Outsourcing of studies to contract laboratories
• Evaluation of biocompatibility for materials and complete devices
• Initial data screening and literature searches
• Preparation of product specific documents, i.e. protocols, reports, medical device dossiers and scientific papers
• Classification of medical devices based on the intended use pattern
• Evaluation of the need for supplementary biological tests before notification to the authorities
• Comparative evaluation of materials, particularly as regards toxicity
• Toxicological risk assessment incl. QSAR
• Scientific and legislative advice