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BioReg experts advise on cybersecurity questions and help medical device manufacturers to design and manufacture products that are safe, secure, and continually monitored against cyber risks.

Cybersecurity has become a growing concern within the medical device industry as more and more connected medical devices are placed on the market.
The increased connectivity means that the healthcare sector is now more prone to cybersecurity risks.

New laws on cybersecurity such as MDCG 2019-16: Guidance on Cybersecurity for Medical Devices; IMDRF: Principles and Practices for Medical Device Cybersecurity; FDA Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions; AAMI TIR-57: Principles for Medical Device Security-Risk Management; ISO 14971-2019: Risk management to medical devices – are aimed to:

  • To protect patient safety
  • To avoid privacy fines under new GDPR
  • To prevent disclosure of personal patient data and health information
  • To reduce the possibility of reputational damage due to a breach


In order to inquire about our services or ask for immediate regulatory advice for your product, contact us.

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