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The majority of my get the job done is in a professional witness part in which I work carefully with Lawyers to provide unbiased viewpoints and determine both of those the strengths and weaknesses of a consumer’s circumstance.

With above ten years of revolutionary expertise inside the regulatory consulting, DDReg stands out for a dependable spouse for medical device marketplace...

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Due to this fact, certification is important to guarantee their ongoing marketability. The introduction of classification policies also necessitates the involvement of a notified entire body for your vast majority of in vitro diagnostic medical devices. A quality management procedure in accordance with ISO 13485 is necessary in both equally scenarios. We support makers to efficiently and effectively satisfy the necessities of your Restrictions on Medical Devices and IVDs.

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We are definitely the professional Get in touch with for all concerns that come up regarding industry demands, medical devices directives and particularly The brand new EU rules on medical devices.