With over 40 years of experience in the medical device industry, Mr. Riggi’s success spans the following industry sectors:

• Ophthalmics
• Orthopedics
• High Volume Device Production
• Cardiac Rhythm Management
• Neurostimulation
• Infusion Technologies
• Medical and Dental Radiation Devices

Mr. Riggi brings this extensive experience to the client in the areas of:

• Global Quality Assurance/Regulatory Operations
• Global quality system development, implementation and assessment.
• Client assistance during third party/regulator audits, inspections and assessments.
• Medical Device Design Control
• Radiation safety
• Regulatory Compliance and Product Submissions
• Client assistance in registration dossier preparation.
• Training on quality system regulations (US, EU, Canada, Brazil, China, Japan, Korea and Russia),
• MDSAP and EUMDR.
• Corporate Compliance Assessment Programs
• ISO/CE Certification Processes
• Vendor Quality
• Enterprise Management System Leadership
• Regulatory/Notified Body Relationships
• Global medical device product registrations (US, EU, Canada, Brazil, China, Japan, Korea, Russia and numerous other jurisdictions in Latin America and Asia).

Whether on the manufacturing floor or in front of large conference audiences, Mr. Riggi’s open and relaxed communication talents ensure maximum value for the client.