Speed To Market business services

Speed To Market Consulting Services has assisted medical devices companies in producing a wide range of products including invasive catheter accessories, patient monitoring devices, and radiological diagnostic and therapy systems.

Speed To Market can assist your company with:

Business Support

• Strategic Regulatory Planning

• Quality Management System Development, Optimization, Auditing and Assessment
• US FDA Quality System regulation
• EU MDD including ISO 9001, ISO 13485 and EN 46001
• Canadian Medical Device Regulations

PRODUCT DEVELOPMENT SUpport

• US Food and Drug Administration 510(k) Premarket Notifications including Traditional, Special and Abbreviated methodologies

• European Union CE Marking and Technical File
• Canadian Licensing
• National and International Standards Interpretation, Assessment and Application including Patient Safety and Electromagnetic Compatibility

Statistical Support  

• Design of experiments

• Multivariate data analysis
• Survey design and analysis
• Graphical data representation
• Mixture designs for formulation studies
• Sample size determination
• Statistical process control (SPC)
• Statistical training
• JMP software training
• Technical writing

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