MD Services

Medical Device Services

Since many years we are working with regulated industries and we can help you reply to your compliance needs.

This could be obtained through an analysis, a study or to an assessment done on the devices, to understand together if there is the right maturity level to be aligned with the requirement of the market your company would like to support.

Our consulting services could contribute to your success in different phases including:

Audit

  • Analyse the products and the data they are processing
  • Make a market analysis to understand any possible conflict with local and industry regulations including GDPR, FDA, HIPAA, ISO 13485, ISO 14971, ISO 29151, ISO 80001 or ISO 81001
  • Assess your devices and run control checks to define a gap analysis against regulations
  • Report findings, understanding an action plan and a roadmap

Design

  • Design controls
  • Define how data should be acquired, processed and disposed

Implementation

  • Make your design to become real
  • Project management
  • Documentation
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Check our guides:

Data Privacy

Data security refers to digital privacy protection measures that are applied to prevent unauthorized access to data, which can be found on computers, databases and websites

Medical Device Security

During the last decades, the medical device market has made enormous progress moving from manual devices, to highly advanced systems, and integrated with the systems of clinics and hospitals.

Check our Training:

HCISPP

The HealthCare Information Security and Privacy Practicioner is the only certification that combines cybersecurity skills with privacy best practices and techniques to show the ability to implement, manage and assess security and privacy controls

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Swiss Identity and Access Management experts

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