BRANDWOOD : BIOMEDICAL Suite 408, 460 Pacific Hwy St Leonards NSW 2065 Australia securing your compliance Office: Fax: +61 (0) 2 9906 2984 +61 (0) 2 8580 4613 [email protected] SAMPLE AGENDAS These are example agendas only. Please contact us to discuss your specific needs so we can tailor a program for you. Introduction to Medical Device Regulations in Australia         Introduction Legislative framework Technical standards and documentation Regulatory guidance Review processes, fees and timelines Manufacturing controls Forthcoming changes Case studies Introduction to Medical Device Regulations in China        Legislative framework Technical standards and documentation Regulatory guidance Review processes, fees and timelines Manufacturing controls Forthcoming changes Case studies ISO 14971 Risk Management       Introduction to ISO 14971 Standard for Risk Management Design Risk Assessment Production Risk Assessment The Z Annexes and relationship to Directives – matches and mismatches Related Risk Analysis Standards (FTA/FMEA/HAZOP/HACCP etc.) Special Cases –ISO 10993, ISO 22442, IEC 62304 IEC 60601 Electrical Safety      Application of ISO 14971 Requirement in the TRF Global Regulatory adoption and local variations Software IEC 62304 and Software Level of Concern ISO 10993 and ISO TR 15499 – biological safety in a risk management framework Brandwood Biomedical Biocompatibility Evaluation using ISO 10993 A Risk management model for efficient testing programs The 2009 revision of ISO 10993 introduced a risk management model which provides a rigorous approach to biocompatibility evaluation, The old “tick list” approach was replaced with a framework which emphasises materials characterisation and targeting testing on the key biological risks, avoiding unnecessary testing. This can cut months from development programs and regulatory approvals and save substantial costs.          ISO 10993 part 1 evaluation requirements and the ISO TR 15499 Risk management model Additional requirements of US FDA (including the G95-1 Blue Book Memo and the 2013 Draft Biocompatibility guidance. Materials characterisation Reducing regulatory and testing risk by smart materials selection Consideration of processing aids and additives such as pigments Selection of testing protocols Special cases e.g. mucosal contact testing, specific tissue exposures How to determine limits for leachables (ISO 10993 part 17). Determination of thresholds of toxicological concern to determine safety of low level unknown contaminants Medical Device software        Medical software design controls Application of IEC 62304 & IEC 62366 US & European software guidance Verification a& Validation Standalone software Mobile apps Product approval requirements in major markets Page | 2