Cybersecurity

To master cybersecurity regulatory requirements

Services and expertise > QARA > Cybersecurity

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Contact Mathieu CHARLEUX on :+33 6 03 17 92 45

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Dedicated experts, a customized solution

Cybersecurity has become a major issue in the healthcare sector.
Completely missing just a few years ago, cybersecurity is now a key requirement in medical device regulations.

MD101 can help you meet your DM cybersecurity compliance requirements:

  • Support for the implementation of cybersecurity requirements throughout the medical device lifecycle in your QMS: standards IEC 81001-5-1, IEC 60601-4-5, AAMI SW96, AAMI TIR5797 and FDA guidance.
  • Support in compiling technical documentation demonstrating the security of the software in accordance with cybersecurity standards and FDA guidelines.
  • Audit of technical cybersecurity documentation in line with CE marking and FDA requirements.

MD101, co-founder of the .emt Alliance

United to support companies in HealthCare

MD101, co-founder of the .emt Alliance

MD101, founding member of The MedTechAlliance, USA

Catalyzing global growth and innovation

MD101, founding member of The MedTechAlliance, USA