Our Expertise

To help your firm, each of member of our team has over 17 years of experience in the medical industry so that you can have access to expertise in all areas of regulatory compliance and Quality System implementation, such as,

  • Auditing
  • CE Marking and ISO certification
  • Design Control
  • Design Validation for Medical Devices
  • Documentation Management
  • Establishment Registration and Product Listing
  • FDA 483/warning letter responses
  • Good Laboratory Practices (GLP)
  • GMP Pharmaceutical Manufacturing
  • Equipment Validation
  • European Medical Device Directive Compliance
  • European Technical Files
  • ISO 9000
  • Medical Devices
  • Metrology/Calibration
  • Pharmaceuticals
  • Preventative Maintenance
  • Process Validation
  • Product Complaint Handling/MDR’s/Vigilance
  • Product Labeling
  • Product Recalls
  • Product Submissions/Registrations
  • Project Management
  • Quality Assurance/Engineering
  • Quality System Implementation/Enhancement
  • Quality System Regulations (QSR)
  • Regulatory Affairs/Submissions
  • Regulatory Inspections/investigations
  • Risk Analysis (FMEA, FTA)
  • U.S. Regulatory Compliance for Medical Devices and Pharmaceuticals
  • Standard Operating Procedure Development
  • Statistical Process Control
  • Supplier Management
  • Training/Seminars
  • Vendor/Supplier Auditing