Unannounced audits by notified bodies
Unannounced audits are random sampling checks of the quality management systems by notified bodies with the aim of Initial experience with unannounced audits is now available.
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Inhaber der Johner Institut GmbH
Regulatory affairs: Service provider, company, individual – liability for mistakes
Many people ask about the liability of individuals, management, and the company. After all, it is not only the Medical Devices Regulations that impose fines and imprisonment. The question of liability also arises for development service providers.
