MEDDEV Regulatory Advantage LLC
Need help navigating the medical device regulatory landscape? MEDDEV Regulatory Advantage can advise you, assist you, or drive the process for you. Specializing in Class I and Class II medical devices. Offering services including but not limited to:
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Medical Device Classification
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FDA 510(k) Submissions
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Establishment Registrations & Device Listings
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Health Canada Medical Device License Applications
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Health Canada Estabishment Licenses
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Postmarket Adverse Event Analysis and Reporting Decisions
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Authoring Medical Device Reports / Vigilance Reports
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Understanding Requirements specific to your devices
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Labeling & Promotional Review
SPECIFICS
What do you need help with?
US FDA
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Register your Establishment
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List your device(s)
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Quality Mngmt System (QMS)
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Author/Submit a 510(k)
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Radiation Safety Regulations
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Author/Submit an MDR
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Execute/Document a Recall
Health Canada
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License your Establishment
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Submit a Medical Device License Application
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Submit a Device License Amendment Application
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Submit an Investigational Testing Authorization
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Author/Submit a Vigilance Report​
International
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Euopean Union Requirements
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Australia/New Zealand Requirements
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How to obtain a GMDN Code
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Declarations of Conformity
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Requirements to market outside the EU/ANZ
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Assemble/Submit Dossiers