YBCA




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MEDICAL DEVICES

YBCA provides a comprehensive range of services on: biological safety evaluation, performance testing, clinical investigation, risk management, quality systems and regulatory compliance of medical devices in Europe, USA and the Rest of the World

  • Guidance on developments in, and application of the EN ISO 10993 series of Technical Standards (20 parts), Biological evaluation of  Medical device. A YBCA Consultant has 18 years experience with the ISO/TC 194 Committee which develops these standards. He is Chairman of the BSI CH/194 Committee which provides UK input; Leader of the British Delegation to the ISO TC; and Convenor of WG14 Material Characterization, which has produced parts 18 and 19 of the ISO 10993 series. He has also actively participated in the development and revision of most of the other parts of the series including the revision of the soon to be published key part 1, Evaluation and testing within a risk management  system
  • Expert assessment and statement of testing needs for your device taking account of all existing preclinical and clinical data available on the components / materials/ formulation ingredients. Identification of appropriate testing facility, as needed, in UK, Europe, USA, Japan or other country.  Wound healing expertise and associated specialist histopathology can be done via YBCA associated laboratory. Study design and monitoring at your chosen testing facility is a service offered including interpretation of results
  • Establishment of allowable limits of leachables using EN ISO 10993-17
  • Guidance on developments in, and application of Clinical Investigations of  Medical Devices for Human Subjects (EN ISO 14155-1, -2)
  • Guidance on developments and application of EN ISO 14971, Medical devices – Application of risk management  to medical devices
  • Guidance on developments in, and application of EN ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes
  • Guidance on the use of the above EN ISO standards to meet the Essential Requirements of the European Medical Devices Directives
  • Training in any of the above areas at a particular venue, or in house training tailored to your specific needs
  • Auditing of quality systems and other processes to meet compliance with the Essential Requirements of the European Medical Devices Directives
  • Guidance on compliance with FDA regulation of medical devices
  • Guidance on compliance with regulation of medical devices in other markets, including Japan, and links to expert consultants in these regions.