Zi-Medical Overview

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Zi Medical provides services globally to medical device, IVD and pharma companies including:  See our company overview.

  • Pre-submission Consultations and Fillings
  • International Regulatory Strategy for One or Multiple Markets or Products
  • International Product Registration and License Renewal
  • GMP/QSD Registrations
  • Regulatory Management Development
  • Quality Compliance
  • Regulatory Staff Training
  • Process Improvement, Six Sigma
  • Regulatory Information Technology Strategy

Major Regions covered include: 

US, EU, China, Taiwan, Hong Kong, Singapore, Japan, Korea, Malaysia, Philippines, Singapore, Indonesia, India, Thailand, Vietnam, New Zealand, Australia, Mexico, Argentina, Brazil.

The Customer is a US based software company who recently involved in medical device industry to develop software for clinical study and patient enhanced experiences. They are seeking a quality and regulatory consultation support for FDA and CE compliance while they developing variety for software to be used either alone or in conjunction with other...