Descriptra

Generator AI de descrieri de dispozitive medicale

Creează descrieri corect din punct de vedere reglementar și tehnic precise pentru dispozitive medicale. AI-ul echilibrează precizia clinică cu text ușor de înțeles.

Conformitate reglementară
Precizie clinică
Text accesibil
Medical Device

Blood Pressure Monitor

FDA 510(k) Cleared

Bluetooth 5.0
Clinically Validated
2-User Memory

Funcționalități

FDA cleared ✓
CE marked ✓
ISO 13485 ✓

Regulatory Language

AI uses compliant phrasing: "intended for," "indicated for use in" — avoiding unapproved medical claims while remaining informative.

Class II
Clearance 510(k)
Standard IEC 62133

Technical Specifications

Accurately presents dimensions, materials, sterilization methods, power requirements, and certification numbers.

FDACEISOIECHIPAA

Certification Highlighting

Prominently displays FDA clearance, CE marking, ISO 13485, and other medical device certifications.

Compliance Score 97/100

Healthcare Professional Tone

Professional, clinical language that builds trust with healthcare buyers and procurement departments.

Cum Funcționează

1

Enter Device Details

Product name, intended use, specifications, certifications, and contraindications.

2

Set Compliance Level

Class I, II, or III device. AI applies appropriate regulatory language depth.

3

Generate Description

Get compliant, professional descriptions with certification callouts.

Vezi-l în Acțiune

Medical Device

Input

Digital blood pressure monitor — upper arm, FDA cleared, Bluetooth, memory for 2 users, irregular heartbeat detection

Output

FDA-Cleared Digital Blood Pressure Monitor This clinically validated upper-arm blood pressure monitor provides accurate systolic, diastolic, and pulse readings for home health monitoring. Bluetooth connectivity syncs data to your smartphone for easy tracking. Dual-user memory stores up to 120 readings per user. Irregular heartbeat detection alerts you to potential arrhythmias during measurement. FDA 510(k) Cleared | Clinically Validated | Bluetooth 5.0

Întrebări Frecvente

Does it follow FDA language guidelines?

Yes. AI uses compliant structure/function language and avoids unapproved medical claims.

Can it handle Class I, II, and III devices?

Yes. Regulatory language depth adapts based on device classification.

Compliant Medical Device Descriptions

Generate regulatory-aware medical device copy. 5 free credits.