ExH as OTS Software
Extra Horizon is an Off the Shelf Software (OTS) platform for Medical Devices. This section explains how to integrate ExH in your Management System and MD documentation.
What is Off-The-Shelf Software ?
Extra Horizon, commercializes its platform as a managed service or solution or SaaS and thus the legal manufacturers have no direct control over the platforms' software life cycle control. Regulations like FDA & MDR provide legal manufacturers with the ability to make use of third party software or Off-The-Shelf (OTS) under the consideration that the necessary documentation can be provided that guarantee safe operation.
Extra Horizon is considered an embedded Off the Shelf Software. This means the end user of the medical device does not select the OTS software and cannot change the software provided by the medical device manufacturer.
How to document ExH as OTS Software in my product ?
In summary, you will need to provide the following elements to include Extra Horizon as an OTS Software component in your product.
The information provided below is based on the guidance document on Off-The-Shelf Software from the FDA.
Depending on your device and its risk to patients, users or others in the environment of use, a Basic or Enhanced Documentation Level is determined for your submission.
As Extra Horizon supports different kinds of devices we don't make a distinction here and support the legal manufacturer to determine the documentation to be included in the pre-sub that is appropriate for their device.
A. Description of the OTS Software
An overview and description of the OTS software and actions taken for the continued safe and effective use of the medical device.
B. Risk Assessment of OTS Software
Risk assessment demonstrating that risks related to the use of OTS software have been appropriately mitigated.
C. Software Testing as part of Verification and Validation
Test plans and results for the OTS software, commensurate with the Documentation Level (i.e., Basic or Enhanced) for the device.
D. Assurance of Development Methodologies and Continued Maintenance of OTS Software
Information to provide an assurance that the product development methodologies used by the OTS software developer are appropriate and sufficient, and mechanisms exist for assuring the continued performance, maintenance, and support of the OTS software.* *Not mandatory to include in the submission for Basic Documentation level devices
A. Description of OTS Software
An overview and description of the OTS software features and functions should be provided in your pre-sub. Legal Manufacturers should consider and, as applicable, provide information to address the questions below when preparing the OTS software description.
What is it ?
What are the Computer System Specifications for the OTS Software
How will you assure appropriate actions are taken by the End User ?
What does the OTS Software do?
How do you know it works?
How will you keep track of (control) the OTS Software?
We have a pre-filled description of Extra Horizon as a OTS Software and the answers to the questions posed by the regulatory bodies (e.g. FDA).
⇒ Reach out to [email protected] to provide you with our example documentation.
B. Risk Assessment of OTS Software
Risk Management is key when creating medical devices. The recent FDA guidance advises to include the risks associated with the functions of the OTS software that is being used in the device into your risk management file.
For every OTS software, the risks associated with the functions of the OTS software used in the device should be documented in the risk management file.
To ease your Extra Horizon integration we have drafted a list of example risks that could be considered when including Extra Horizon as part of your Medical Device.
Together with these example risks we have drafted a list of mitigations measures that Extra Horizon takes to help you prove the identified risks are mitigated.
⇒ Reach out to [email protected] to provide you with our example documentation.
C. Software Testing as Part of Verification and
Validation
Legal Manufactures need to include documentation regarding test plans and test results as part of the verification and validation activities for the OTS software. The FDA guidance mentions that legal manufactures should also include the testing activities performed by the legal manufacturer itself as part of the qualification process.
Our goal exists of easing the path for our customers as much as possible. Therefore, Extra Horizon builds and operates its software lifecycle processes according to IEC62304 within the context of an ISO13485 certified quality management system. This ensures you can fully rely on the documentation and third party certificates Extra Horizon provides to you as a customer and require little to no verification and validation efforts from your end.
Extra Horizon generates compliant documentation for every release of our software. This also includes Software testing and verification.
Our compliance team will assist you and provide the necessary documentation so you can:
Describe testing of the OTS software and demonstrate it is appropriate and adequate for the hazards associated with the OTS software as documented in the risk management file
Provide the results of the testing performed at Extra Horizon
A list of known anomalies associated with the version of the services your are using
⇒ Reach out to [email protected] to provide you get in contact with our compliance team.
D. Assurance of Development Methodologies and Continued Maintenance of OTS Software
Legal Manufacturers should document this information about the OTS Software they use via the DHF of the device. Whether you need to include it in your pre-market submission depends on the identified documentation level (Basic or Enhanced). However, the FDA can always request additional information on this, even for Basic documentation Level.
Again Extra Horizon is here to assist you and make your life as easy as possible:
D.1 Assurance of development methodologies
The FDA requires you to provide assurance that the product development methodologies used by the OTS software developer are appropriate and sufficient for the intended use of the OTS software within the specific medical device.
For example, this may include a review of the OTS software developer’s design and development methodologies used in the construction of the OTS software. This review should thoroughly assess the development and qualification documentation generated for the OTS software.
If such an assurance is not possible, and if the residual risk evaluation of the hazardous situation after implemented risk control measures is not acceptable as defined in the risk management plan, the use of such OTS software may not be appropriate for the intended medical device application.
As part of the example risks and mitigations of section B, we have included the risk for the legal manufacturer of not having any control over the design and development methodologies of Extra Horizon.
Extra Horizon has implemented a management system that is compliant to (ISO13485, ISO27001 & ISO27701). Our Software development Methodologies are compliant to IEC62304.
⇒ Reach out to [email protected] to provide you with our example documentation.
D.2 Assurance of continued maintenance
For each OTS Software you will need to assure continued maintenance and support. Extra Horizon will typically play an important role as a critical supplier for you as a legal manufacturer.
Extra Horizon's contracts include a clear Service Level Agreement (SLA) that contain clear commitments from Extra Horizon to properly operate, maintain, monitor and support the platform that is provided to you.
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