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?
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?