FDA Consulting
From 510(k) consulting to QSR implementation,
we can help you obtain
FDA clearance for your medical device.
We provide medical device consulting services to medical device companies of all sizes. From 510k marketing clearance to FDA QSR / ISO 13485 compliant medical device quality systems to assistance with post market issues, we provide comprehensive medical device consulting solutions. FDA quality compliance can be a challenge. We help your medical device company effectively navigate the FDA compliance process and stay on track!
Our medical device consulting services are a valuable asset to your team. Whether their time is at a premium or access to needed expertise is limited, our medical device consulting services help your company meet FDA medical device requirements.
Our services are available for specific projects or individual tasks. We can assist your team with 510k preparation or review, replying to 483s, determining appropriate corrective actions and deciding how to best comply with FDA medical device requirements.
We can also identify appropriate suppliers, develop needed processes and help your company ensure overall quality and regulatory compliance. From medical device product development to post market surveillance, our medical device consulting services help your business navigate the medical device quality and regulatory compliance process. Medical device startup or small business clients are welcomed!
FDA consulting services we offer:
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FDA 510(k) submissions for obtaining FDA clearance
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FDA Investigational Device Exemption (IDE) submissions for US clinical studies
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FDA Requests for Classification and Requests for Determination
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FDA Pre-Submission (Pre-sub) meetings
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FDA QSR Consulting (21 CFR Part 820) for medical device and IVD manufacturers
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FDA QSR training for medical device companies
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QSR (21 CFR Part 820) audits for medical device companies and their suppliers
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FDA Form 483 Warning Letter analysis, response, and recovery
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General regulatory and quality system assistance and training
Why choose BioVision as your FDA consulting firm?
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We offer effective FDA regulatory support for all sizes of firms, from small, start-up medical device companies to large, multi-divisional corporations.
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Our FDA consulting services are fully tailored to address your particular business needs.
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Our FDA consulting and project management teams coordinate efforts to deliver your services on time and within budget.
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We maintain constant accessibility and support both on- and off-site during the course of your FDA consulting project.