Services: Medical Devices

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Regulatory Strategy & Due Diligence

Lead the meetings preparation & due diligence assessments for medical device products.

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Quality Systems & Training

Assist with Quality System documentation development including expert technical reviews of software development procedures.

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FDA Submissions

Prepare or assist in the preparation of regulatory submission for medical devices

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FDA Meeting Preparation & Engagement

Assist clients in preparing for FDA meetings and FDA Advisory Panel meeting.