IVD manufacturer and service provider

#1
Hello all! Can someone help me know if a manufacturer of IVD e.g A and becomes a service provider of A to the customer directly?
National regulations govern manufacturing whereas ISO sope governs the mfg, design, development, and service for diagnostics.
How should the company handle this scenario of risk management?
Who should be considered the customer of such an organization?
How will the organization record and notify consider its Adverse drug reaction to regulatory?
 
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#2
A repost for attention !!

Hello all, can someone help me know with below points for IVD class III:
Scenario:
Organization ACB is manufacturing an IVD Class III also using the same for the device directly for the patients.
• ISO 13485 Scope covers the manufacturing, diagnostics, design, and development (listed as follows 14971)
• National regulatory bodies have provided the license to mfg. sale and distribution of this device
• A separate license for diagnostics is procured by the organization
Questions:
1. How does the organization justify its customers as internal members of the organization?
2. How should the organization plan for customer feedback?
3. In which areas should be risk assessed?
4. Does it also need to follow any other ISO standards?
5. Reporting to authorities based on ADR/ADE how will these scenarios ever reach the authorities?
6. How should the organization justify its risk to benefit assessment?
 

indubioush

Quite Involved in Discussions
#3
1. How does the organization justify its customers as internal members of the organization?
2. How should the organization plan for customer feedback?
3. In which areas should be risk assessed?
4. Does it also need to follow any other ISO standards?
5. Reporting to authorities based on ADR/ADE how will these scenarios ever reach the authorities?
6. How should the organization justify its risk to benefit assessment?
1. Customers are not internal members of the organization.
2. You need to develop a customer feedback process for obtaining feedback, determining whether it is a complaint, whether it is reportable, etc.
3. All areas.
4. The ISO standards you need to follow depends on your product and your regulatory pathway.
5. You need to communicate to your customers that they should notify your organization of any ADR/ADE. Then you will report as needed.
6. By backing up the assessment with risk management documentation, literature reviews, clinical data, physician input, and marketing assessments.
 
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