- Cybersecurity Governance
- Risk Management
- Compliance
- Cybersecurity Management System
- Medical devices standards & regulations
Key challenges
Our Customer is active in the healthcare sector with more than 3,300 employees worldwide, which operates in a variety of business areas, and in our case, in medical devices manufacturing.
For each project/product released in a specific market/country, our customer needed to manage all aspects regarding cyber security and data protection regulations, through defined and compliant processes.
Our approach
With the help of our experts, our client was able to define, establish and implement all the activities and processes necessary for risk management, compliance with the laws of various markets (Switzerland, Europe, USA, Canada, etc) and governance of cyber security and protection of data of its organization.
Standards and regulations such as NIST Framework, GDPR, FDA cybersecurity Guidance’s, HIPAA, MDR EU, MDCG , PIPEDA, ISO 2700X, etc were used and adequately executed.
Benefits
While improving security measures to address risks related to cyber security and data protection, our client has developed an information security culture and behaviors through all of its activities, and in the entire product life cycle of medical devices.
Most important, our customer was able to define a cyber security and data protection strategy, establish and implement a cyber security Management System, and continuously ensure to manage properly all cyber security requirements through all the organization, and worldwide.
Thanks to our
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