ABOUT

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 medical device submission and registration renewal projects.   

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Astute Consulting IMDC’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 (OUS).

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Our extensive medical device submission and registration renewal experience allow for a best practices approach by leveraging prior submission and registration renewal experience from the following countries:

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• European Union (EU)

• Canada

• Brazil

• China

• India

• Egypt

• Mexico

• Vietnam

 

Additionally, Astute Consulting IMDC has experience in technical documentation (Tech File) compilation and remediation that includes a diverse category of medical devices such as:

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• Annuloplasty Rings (Mechanical Heart Valve)

• Aortic Valve Bioprosthetic

• Vascular Grafts

• Surgical Mesh (Bio-surgery)

  • Coated and Uncoated (Bare)

• Chest Drains and Chest Drain Accessories

• Endovascular Stent (Balloon Coated Stent)

• Electrosurgical System (Orthopedic; Spinal; Neurological procedures)

• Endoscopes

 

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Astute Consulting IMDC understands that the successful compilation of technical documentation requirements needed to obtain market approval and/or clearance relies on cross-functional collaboration and the vital role it plays within any organization (medical device manufacturer). As such, our hands-on approach – working closely with your company’s process owners (functional groups) – allows for an efficient cross-functional collaborative workflow process wherein, technical documentation requirements are defined among the various functional groups (i.e. QA; R&D; Marketing, etc.).  The results of which can serve as a methodology in support of the Regulatory Affairs department’s documentation compilation (dossier) efforts for a specified medical device submission or registration renewal project.