SERVICES
Astute Consulting IMDC leverages its extensive experience with global medical device submission and registration renewal to support your Regulatory Affairs global projects. As such, ACIMDC can assist you with developing a strategy to efficiently compile the technical documentation required for regulatory submissions and other Regulatory Affairs commitments to enter and maintain a market presence.
Global Submissions
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Registration Renewals
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Documentation compilation for medical device submissions and registration renewals
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Hands-on cross-functional collaboration with your company’s process owners to communicate regulatory strategies, timelines, and technical documentation requirements to drive timely deliverables in support of medical device submissions and registration renewals
EU MDR Transition
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Tech File Remediation
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Annex I
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ERC/GSPR Gap Assessment as applicable
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Annex II Technical Documentation Compilation
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Annex III strategy support (i.e. PMS Plan; PMCF; PSUR; SSCP; PMS Report)
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Technical Documentation (Tech File) remediation in response to notified body audit review and/or implemented regulations
Written Responses to Regulatory Agencies and Notified Bodies
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Assist with drafting written response requests from Regulatory Authorities
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Provide applicable regulatory input to resolve questions or issues (i.e. audit findings) raised by Notified Bodies and Regulatory Authorities