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Classification (Demarcation)

SKU 364215375135191
Price

€850,00

The classification of a medical device is essential to understand the requirements laid upon the technical file during product development, as well as post market reporting. Get it right the first time and invest in a proper analysis.

 

The Report

  • MDR Compliance: Dive into precise European Medical Device Regulation (MDR) requirements tailored to your device.
  • Global Market Classification: Understand how your product is classified internationally.*
  • Competitor Analysis: Identify your main competitors and gain a competitive edge.*

 

Why Choose Us?

  • Expertise: Our team of industry specialists ensures accurate, up-to-date information.
  • Fixed-Price Report: Transparent pricing for valuable insights.
  • Actionable Recommendations: Be compliant and understand consequences of the classification.

 

*| Applies to extensive reports 

Report Depth

Quantity

PRODUCT INFO

The reports contiain the following information:

Area Scope or report Input
EU

What MDR regulations appliy and what is the classification of the device? What does this mean for compliance?

Customer

query

EU

What MDR regulations appliy and what is the classification of the device? What does this mean for compliance?

What are the main competitors in Europe? What devices do they have and what are their specifications. 

Customer

query and 

Interview

Worldwide

Worldwide Regulations,

competition and reflection

  1. Regulatory Options
  2. Comparable Medical Devices
  3. Options for the company

Customer

query and 

Interview

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