Skip to content

Define intended purpose and control medical claims - #132

Merged
KeyffMS merged 5 commits into
mainfrom
agent/issue-89-intended-purpose
Jul 29, 2026
Merged

Define intended purpose and control medical claims#132
KeyffMS merged 5 commits into
mainfrom
agent/issue-89-intended-purpose

Conversation

@KeyffMS

@KeyffMS KeyffMS commented Jul 29, 2026

Copy link
Copy Markdown
Owner

What changed

  • record the intended users, environment, function and exclusions for SightAdapt 0.5.0.50-alpha;
  • position the current product as general-purpose accessibility/display-personalization software without an intended medical purpose;
  • prohibit diagnosis, treatment, therapy, clinical-effectiveness and named-condition claims;
  • define approved terminology and a non-medical-purpose statement;
  • record the repository, About, release, support, brand and external-surface review scope;
  • require a new qualified EU medical-device regulatory assessment before medical targeting, clinical workflows or related claims;
  • apply the policy to README, brand, release and store-description rules.

Scope

Documentation and claims governance only. Application behavior is unchanged. No professional classification opinion is claimed.

Closes #89.

KeyffMS added 5 commits July 29, 2026 22:16
Signed-off-by: KeyffMS <124252104+KeyffMS@users.noreply.github.com>
Signed-off-by: KeyffMS <124252104+KeyffMS@users.noreply.github.com>
Signed-off-by: KeyffMS <124252104+KeyffMS@users.noreply.github.com>
Signed-off-by: KeyffMS <124252104+KeyffMS@users.noreply.github.com>
Signed-off-by: KeyffMS <124252104+KeyffMS@users.noreply.github.com>
@KeyffMS
KeyffMS merged commit ebdd27c into main Jul 29, 2026
2 checks passed
Sign up for free to join this conversation on GitHub. Already have an account? Sign in to comment

Labels

None yet

Projects

None yet

Development

Successfully merging this pull request may close these issues.

[Regulatory/Claims] Maintain the general-purpose non-medical product scope

1 participant