SaaS Update Policy

BioT platform is Software as a Service (“SaaS”) that is updated in regular intervals.

SaaS Major Updates

"Update" means a subsequent release of a new version of the BioT platform. As part of the SaaS operation, we release new versions of our platform occasionally and make it available for our customers at no additional fee.

Our Policy for Major Updates

  • Major updates are continuously released at a rate of about once every 2 months and announced to the customer base.
  • Every major update is accompanied by an updated design history file (DHF) and release notes detailing the new features, fixed issues and known issues of that update.
  • Updates are backward compatible and do not break existing services. In the rare case where an update is not fully backward compatible it is clearly communicated in advance and a migration plan is agreed with affected customers.
  • For a duration of 3 months from announcements of a release of a new major update, hot fixes for support issues/faults are provided for that release. Crossing 3 months from the release of a major update hot fixes stop being issued for that release. Resolution of faults in versions older than 3 months requires customers to upgrade to the latest version.

Major Update Deployment

BioT updates are not mandatory and are applied on customer accounts following customer approval and in coordination. As a best practice BioT encourages customers to closely follow BioT's major update announcements and upgrade as soon as possible to avoid cases where a critical issue is found in a version that is no longer supported.

Hot Fixes

BioT performs the vast majority of product testing during the development cycle of a new release. The development of every new feature includes manual testing and creation of automated unit tests.

Either we or our clients nevertheless sometimes find bugs in released builds. In most cases, we fix these problems as part of the next release cycle. If a problem is discovered on an old version which is still in the 3 month maintenance window, and its severity is high enough, we will consider fixing the customer environment as a "hotfix".

A "hotfix" is a software patch issued for an environment that is outside of the regular development cycle. Depending on the complexity of the problem, BioT will communicate to the customer how long will it take to solve it, and the impacts that this might have on the platform availability.
BioT will schedule the "hotfix" deployment with the customer and inform him when the deployment is done.

Regulatory Change Control

As of early 2023, regulation for change (aka updates) control of procured software as a service is still being forged. Therefore at present updates to procured IaaS / PaaS / SaaS are not considered a risk in the eyes of the FDA and MDR, and many devices powered by cloud vendors who changed their software daily have been approved. The most updated guidance is in the form of the CR510:2021 consensus report - Appropriate Use of Public Cloud Computing for Quality Systems and Medical Devices - issued by the The Association for the Advancement of Medical Instrumentation® (AAMI). During 2023 AAMI is expected to release a technical information report, AAMI TIR 115, which may be adopted by the FDA. BioT is a part of the working group creating AAMI TIR 115.

For more information about this policy please contact us.