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Bishop Regulatory Consulting

Contact:  Bonnie Bishop, RAC
Specialty: Medical Devices

  • 510(k) submissions
  • PMA submissions - Original, Supplements, Annual Reports
  • European CE Design Dossiers and Technical Files (class 1, 2b and 3 devices)
  • US Investigational Device Exemptions (IDE) and Clinical Study Applications
  • Regulatory Strategy
  • Quality System Development, Implementation and Compliance
  • Internal and Supplier Auditing
  • Regulatory Audit Support
  • Due Diligence
  • Regulatory and Quality Training

Years in business: 1 yr. 3 Mo (Since June 2017)

 

 Phone: 714-287-3359
 Email: This email address is being protected from spambots. You need JavaScript enabled to view it.