Essential ISO 13485 requirementsand MDSAP Model Marcela Ivankovich

Are you a supplier for a medical device company? Then you must be aware of the impact on your customers of Medical Device Single Audit Program (MDSAP) and the Medical Device Regulation (UE MDR) 2017/745 . You may be familiar with the supplier selection, evaluation and receiving inspection processes. However, Health Ministries around the world have clarified their expectations regarding the supplier controls that Medical Device companies need to have in place to sell in their markets and ensure patient safety. It´s important to understand your customer needs, especially risk management activities that drive the level of control over your products or services. Let us guide you. Join us at the Medical Device Supplier Control Readiness training.

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