About

Our company offers expertise in the life science industry including:

  • Medical Device (Class I, II, and III)
  • Combination Products
  • Pharmaceuticals
  • Animal Health

The diverse background and education we bring has allowed us to work with companies big and small to achieve success in this competitive and regulated industry.  Our specialities include:

  • Quality System Management
    • Gap analysis
    • Procedure, form, template authoring
    • ISO or FDA audit preparation
    • Conduct QMS Training
    • Internal Audits
    • Establish Complaint Reporting System
    • Establish CAPA procedures and tracking process
    • Complete CAPA investigations & provide response
    • Failure Investigations
    • Maintain supplier quality agreements
    • Management reviews
  • Product Development Support
    • Technical design reviews
    • Requirements generation
    • Risk Management file including FMEAs, hazard analysis, and risk/benefit analysis
    • Sterilization specification & validation
    • Product verification & validation testing
    • Product material selection
    • Product packaging design & full scope of packaging/shipping validation
    • Labeling specification & development
    • Tolerance stackups
    • Design controls/requirements management & content generation
    • Clinical trial site/product preparation & management
  • Regulatory Compliance
    • 510k submissions including determining product class and predicate device
    • Biocompatibility Assessment and Schedule
    • Provide recall guidance and mitigation for governing body’s review
    • CE mark preparation
    • Technical File preparation
    • Regulatory body audit preparation & guidance
    • Regulatory remediation
  • Project Management
    • Define project scope
    • Establish project timelines
    • Assess possible vendors and assist contract negotiations
    • Maintain project budget
    • Qualify & evaluate candidates for internal roles 
  • Manufacturing
    • Process Development
    • Process Validation including sample size justification & statistical analysis
    • Full validation protocols and reports
    • Fixture and Tooling design
    • Clean room validation support
  • Technical Marketing
    • Generate technical information for marketing information
    • Instructions For Use (IFU)

Ready to see what Kasota can do for you?  Contact us today for a complimentary evaluation!

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