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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.
FDA Warns Korean Device Maker After Follow Up Inspection
Healthcare companies that track user data with mobile apps and the like may be impacted. Some US companies who do business in the UK are wondering whether they need to update their GDPR notices or take other steps now that the UK has officially left the European Union. The answer is: Not yet. The threat of a "Hard Brexit"...