Bonnie Bishop

Experience

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  Bishop Regulatory Consulting

  Jun 2017 - now

  Principal Consultant

  Key Services Offered:• US regulatory submissions for class 2 and 3 medical devices o 510(k) submissions o Original PMA submissions (modular and full submission formats) o PMA supplements o Annual Reports• European CE Design Dossiers and Technical Files (class 1, 2b and 3 devices)• Clinical Study Applications including US Investigational Device Exemptions (IDE) submissions, supplements and annual reports, EU submissions and Investigator Brochures• Extensive interface with FDA, EU Notified Body and international competent authorities regarding clinical studies, pre-market submissions, inspections, compliance, supplements and annual reports.• Regulatory Strategy• Quality System development, implementation and compliance for US and Global regulations and standards including ISO 13485• Internal and Supplier Auditing • Regulatory Audit Support • Due Diligence• Regulatory and Quality Training Show less