professional Services

Cybersecurity -  the Risk Analysis 

The FDA guidance for Management of Cybersecurity in Medical Devices suggests that manufacturers perform a Risk Analysis approach to the cybersecurity management of there devices.  Promenade Cybersecurity experts can assist you through the process, identifying and documenting the risks from your device's potential threats and vulnerabilities.  We will help you to assess the potential impact to the end-users and patients, if the devices loses functionality or data integrity is compromised. 
If your device can connect to a network,  your device's vulnerabilities may be exploited to breach the security of the network, and that too will be addressed. We will advise you on suitable mitigation strategies to adhere to regulatory expectations, and the risk acceptance criteria established. 

Premarket Cybersecurity Functions 

Promenade Software Security Experts can help you decide on appropriate cybersecurity activities for your device. Often several options are available to mitigate the determined risks, and your device specific technologies will be used to determine the best fit for you. We will provide the options for:

  1. How to Limit access to Trusted Users Only
  2. How to ensure the content can be trusted, and is not compromised.
  3. How to detect secuirty compromises, and respond accordingly
  4. How to make sure the device is recoverable, in the case of compromise.
Frances Cohen of Promenade Software discussing Cybersecurity for the Med Tech Monday Conference in Irvine.

Cybersecurity - Documentation 

Promenade Software Services can guide you through the creation of the regulatory documentation to ensure your submission goes smoothly. We will collect the information for you, and help you:

  1. Create a list of all cybersecurity risks considered
  2. Create a list and justification for all controls that were established for your device, and verify they are listed in the device requirements
  3. Create a traceability matrix of risk to controls
  4. Create a plan for software upgrades.
  5. Document summary of controls that will assure that the device software will maintain its integrity
  6. Create instructions for use, as it pertains to maintaining cybersecurity for the intended use.


Promenade Software has expertise and solutions to help you make sure your device is secure, and can pass the toughest regulatory audit. 

About Promenade Software

Promenade Software, Inc. specializes in software development for Medical Devices and other safety-critical applications.

Contact

Promenade Software, Inc.
16 Technology Drive,  Suite 100
Irvine, CA 92618 
U.S.A.
info@promenadesoftware.com
(949) 329-8570
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