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...
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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.
Serious vulnerabilities found in certain MedTronic MyCareLink medical devices would allow an attacker within Bluetooth signal proximity to modify or fabric patient data.
As businesses work on compliance with the California Consumer Privacy Act (CCPA) a new proposal deals with the notice of the: