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.

Regulatory Assessment SaMD US/EU

01/21/2021

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...

Serious vulnerabilities found in MedTronic MyCareLink medical devices

12/15/2020

Serious vulnerabilities found in certain MedTronic MyCareLink medical devices would allow an attacker within Bluetooth signal proximity to modify or fabric patient data.

California AG Proposes “Modifications” to Consumer Privacy Act (CCPA)

12/15/2020

As businesses work on compliance with the California Consumer Privacy Act (CCPA) a new proposal deals with the notice of the:

Zi-Medical Overview