Astute Consulting International Medical Device Consultancy (ACIMDC) serves as a Regulatory Affairs resource for medical device companies that need a short- or long-term consultant to support their global (regions outside the United States [OUS]) medical device submission and registration renewal projects.
ACIMDC’s niche service can compile required documentation for medical device submissions, registration renewals, and written responses for requested information from Notified Bodies, Regulatory Agencies and Global Health Authorities outside the United States.
Astute Consulting’s extensive medical device submission and registration renewal experience allows for a best practices approach by leveraging prior submission and registration renewal experience (i.e. Canada; Taiwan; Brazil; Egypt; India; Ukraine; Mexico; China).
Additionally, Astute Consulting IMDC has experience in technical documentation (Tech File) compilation and remediation that includes a diverse category of medical devices (i.e. Vascular Grafts; Surgical Mesh; Chest Drains; Endovascular Stent; Fetal Vacuum Extractors; Electrosurgical System).
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