andreafinato

Andrea Finato provides business development and regulatory affairs consultancy to medical device, in-vitro diagnostic and related companies, including partner search and selection projects. Strategic business reviews & planning, marketing,research and product management from concept to market. Preparation for FDA inspections or Notified Body audits, including mock audits and internal auditor training. Regulatory documentation to comply with European Union Directives or FDA requirements. Pragmatic quality system development for starts-up through to multinationals that meet the international requirements of ISO 9001:2000; US FDA Good Manufacturing Practices GMP); and ISO 13485: 2003 Medical devices – Quality management systems – Requirements for regulatory purposes. Marketing communications advice, including full multimedia services. Validation procedures for processes, products and software.