Regulatory Landscape Monitoring and Reporting – Medical Device

CHF99.00 / 1 month

With advanced technologies, Avanti Europe monitors and reports on any change or update on Regulations, Standards, and Guidelines important to the medical device industry. The report contains the tailored monitoring of the following sources:

  • ISO
  • IEC
  • EU Regulations
  • ASTM
  • US FDA Regulations
  • FDA Guidelines
  • EC Guidelines

Please provide your list of standards, guidelines, and regulations to be monitored in the notes at the point of sales or send it to monitoring”at”avanti-europe.ch.

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Description

The MDR 2017/745, as well as the IVDR 2017/746, define and demand to use of harmonized standards or other standards for purposes of maintaining the state of the art of the product technology and development. This is especially cumbersome in the medical device industry as many standards exist, standards undergo a 5-year lifecycle and new standards evolve continuously. We monitor and report on any updates and changes for regulations, standards, and guidelines. The report is sent monthly to your email inbox and tailored to the standards, regulations, and guidelines of your interest from the current monitoring list you have provided and our monitored sources.

Updates to the monitored sources will be communicated to you to update the monitoring list at no additional cost.

Additional information

Duration

Subscription on a monthly basis; can be cancelled anytime