Evolution of Medical Device OEM

Hydrocolloid Dressing Technology Transfer

I. The Compliance Cornerstone of Technology Transfer

The core parameters of the Hydrocolloid Dressing (Registration Certificate No.: Su-Xie-Zhu-Zhun 20232140894) have been verified through statutory testing and are safe for repeated use:

Structural Composition:

• Sodium Carboxymethyl Cellulose (CMC) Content: 25%-30% (Infrared Spectroscopy)

• Polyurethane Backing Thickness: 0.25±0.05mm (Measured by Micrometer)

Performance Specifications:

• Adhesion: 0.8-1.2 N/cm (180° Peel Test, YY/T 0148 Standard)

• Fluid Absorption: ≥15g/100cm² (YY/T 0471.1 Wick Test)

II. Addressing Clinical Pain Points

1. Nursing Difficulties in Medical Institutions

• Highly exuding wounds: Traditional dressings easily macerate surrounding skin.

• Fragile epidermis: Strong adhesive tapes cause skin tears upon removal.

2. Hydrocolloid Solutions
Precise Adhesion Control (0.8-1.2 N/cm):

• Sufficient to secure the dressing, preventing displacement (clinically measured displacement rate ≤3%).

• Pain score upon removal is only 1.8 (on VAS scale, compared to 4.5 for traditional dressings).

Fluid Locking to Prevent Maceration:

• CMC gel expands upon contact with exudate, forming a barrier; periwound skin maceration rate reduced by 90%.

III. Technology Transfer Pathway under New EU MDR Regulations
List of Reusable Modules

IV. Hard Indicators of Production Quality Control

• CMC Content Fluctuation Control: Tolerance ±2% (HPLC testing; Batch No. KLL-RM202405).

• In-line Adhesion Monitoring: Sampling checks conducted at the start, middle, and end of each roll (data uploaded in real-time to MES system).

• Clean Production Environment: Class 100,000 (ISO 8) cleanroom (GMP Certification No.: Su-Yao-Jian-Xie-Sheng-Chan-Xu-20220338).

V. Contraindications and Operational Warnings
Scenarios where use is prohibited:

• Infected wounds (explicitly contraindicated in the instructions).

• Allergy to sodium carboxymethyl cellulose.

Replacement Guidelines: Replace the dressing when its color turns white (indicating full absorption). The maximum wear time is 7 days.