What design elements must be included for medical tech products?
Regulatory and Compliance Information
- Inclusion of mandatory certifications such as ISO, CE, or BIS marks.
- Registration numbers and license details are displayed as required.
- Country of origin and manufacturer information is clearly mentioned.
- Labels meet the guidelines of relevant health authorities and import rules.
- Expiry dates, batch numbers, and serial codes are placed accurately.
Clear and Accurate Labeling
- Product name, type, and intended use are prominently printed.
- Key specifications such as size, dosage, or technical details are included.
- Warnings and contraindications are stated in an easy-to-understand format.
- Instructions for use are simplified and placed where visible.
- Label text avoids ambiguity and ensures precision in critical areas.
User-Centric and Accessible Design
- Fonts are legible with appropriate sizing and color contrast.
- Information is organized in a clear hierarchy for quick scanning.
- Icons and pictograms support multilingual understanding.
- Design accommodates use by both professionals and end-users.
- Packaging structure supports easy opening and resealing where applicable.
Sterility and Protection Cues
- Tamper-evident seals indicate safety and product integrity.
- Labels denote sterile conditions if applicable.
- Sealing methods and indicators help users identify usage conditions.
- Material choice ensures protection against contamination, moisture, and damage.
- Surface finishes are chosen for clean handling and visibility.
Digital Integration and Traceability
- QR codes or barcodes are used for inventory and tracking.
- Scannable information links to user guides or regulatory details.
- Serialization supports anti-counterfeit verification and recalls.
- Digital records are referenced using printed identifiers on packaging.
- Coding aligns with hospital or institutional inventory systems.
