KEY ISSUES

GLOBAL MARKET STRATEGY
Refinement/development of initial strategy

DESIGN CONTROL
Development of systems and processes to document product development, preparation of design and development plan, identification of user requirements and technical specification development, initiation of preliminary risk analysis.

QUALITY SYSTEM
Identification of initial requirements and development of necessary systems - especially document and data controls, corrective action, and management oversight systems

PREMARKET SUBMISSION CONSIDERATIONS
Identification of relevant product safety/efficacy information for regulatory submissions.

CLINICAL TRIAL CONSIDERATIONS
Determination of study scope, data requirements and reporting methodologies, identification of appropriate sites and investigators, and conduct of pre-investigational assessments.

As your project proceeds, you will need to address many issues: "Everything seems to indicate that it will work well, but how can I prove it - and convince the appropriate regulatory bodies that it does?"

MDCI can help you to define labeling claims and associated supporting clinical study requirements, as well as serve as your liaison with the FDA, Registrars, and Notified Bodies:

  • Pre-IDE Meetings with regulatory agencies to introduce product and present/negotiate pre-clinical and clinical test plans

We can assist in preparation of study materials and provide temporary on-site regulatory staffing and support:

  • Literature reviews
  • Clinical protocols
  • Case Report Forms (CRFs)
  • IRB/Ethics Committee submission materials and informed consent documents
  • Site/investigator identification and qualification
  • Study handbooks and investigator agreements

We also deliver thorough design control and quality system support:

  • Design control, including risk management and design validation
  • Quality system organization and procedure development to requirements of FDA Quality System regulation, ISO 9001, ISO 13485, EN 46001, Medical Device Directives, and essential requirements
  • Corrective/preventive action programs
  • Document control systems

    • NEXT STAGE: TESTING & VALIDATION

Speak with a Consultant

Reach our Massachusetts office at 1-508-643-0434, Monday through Friday, 9:00 a.m. to 5:00 p.m. Eastern. Or click here and a consultant will contact you directly.
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