Regulatory Compliance
Medical device regulatory compliance involves adhering to various regulations, and standards to ensure that medical devices are safe and effective for their intended use.
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Navigating the complex regulatory landscape can be challenging. At SageMar Medical, our team offers in-depth knowledge of regulatory requirements and provides strategic guidance to ensure your products meet all necessary compliance standards.
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Our regulatory strategies provide the roadmap for development and are the starting point to a successful journey to product launch. With extensive expertise, SageMar Medical has developed an efficient and comprehensive method to ensure your submission's success. We offer regulatory support and guidance in the following areas:
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Regulatory Strategies
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Regulation requirements and classification​
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Submission Pathway
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Verification and Validation plan
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​Q-Submission Program
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Pre-submission​
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Submission Issue Request (SIR)
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Breakthrough Designation
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Premarket Notification
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Traditional 510(k) Submission​
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Special 510(k) Submission
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De Novo
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Request for Information​
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513(g) for classification and regulatory requirements
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​Small Business Qualification
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Registration and Listing
