What must happen before a human device study.

Form the entity before a financing or manufacturer application.

Norysr is not yet incorporated. The site does not invite investment. The team will not accept money or promise equity until incorporation and a lawyer-prepared transaction. Any later securities distribution needs advice on the applicable exemption, eligible purchasers, transfer restrictions and owner count; a public website is not a private placement channel.

Intended use controls the regulatory question.

EEG-Clear is described here only as computational research software. It has no diagnostic, treatment or clinical management claim. That label alone does not determine regulatory status: Health Canada assesses intended use, function and representations, including website language. A future wearable that electronically stimulates a child’s leg would be an active therapeutic device; its final risk class requires formal assessment of the completed design and all applicable classification rules.

We will not describe the gait concept as detecting or treating a condition, or as ready for patient use, on the strength of the EEG study or software scaffold.

Protocol, ethics and authorization before use.

For an unlicensed Class II, III or IV device imported or sold for investigational testing involving humans in Canada, Health Canada requires an investigational testing authorization. The manufacturer or importer applies. Institutional research ethics board approval is also needed before a study begins under the relevant institutional and Health Canada requirements. We plan to work with a qualified paediatric rehabilitation hospital or university team and obtain the applicable approvals before enrolling participants or energising output.

TCPS 2 applies to research under eligible institutions, including their unfunded projects. Norysr intends to follow its principles even while independent. A partner’s data sharing, privacy, publication and IP terms must be reviewed before signature.

Build the safety system before an investigational device.

Planning references include ISO 13485 quality management, ISO 14971 risk management, IEC 62304 medical-device software lifecycle and the applicable IEC 60601 electrical safety standards. These are future design and evidence tasks, not certifications Norysr currently holds. For later Canadian sale, Class II to IV devices require a medical device licence; importers and distributors generally require a medical device establishment licence, subject to the regulatory exemptions that apply to their activities.

Rights and evidence travel with every dataset and claim.

The PhysioNet EEG Motor Movement/Imagery Dataset lists an Open Data Commons Attribution licence. Its use requires attribution. Each other data candidate remains unapproved until its licence, any data-use agreement, consent scope, commercial-use terms, privacy terms and redistribution limits are recorded. Restricted PhysioNet datasets can carry additional agreements.

Public claims must match the evidence and the overall impression of the page. We separate public healthy-adult EEG measurements from paediatric, clinical, hardware and stimulation hypotheses, consistent with Canada’s rules against materially misleading representations.

Reference points for review.

• Ontario Securities Commission: NI 45-106 exemptions
• Health Canada: software as a medical device
• Health Canada: investigational testing authorization
• Health Canada: device licensing
• TCPS 2 scope
• PhysioNet EEGMMIDB
• Competition Bureau: misleading representations