Medical Component Development Injection Molding Specification Communication Form

Medical Device Component Development

Injection Molding Specification Communication Form

[User Guide]
Thank you for using this specification form. In medical device development, precise specifications reduce communication costs and risks. Please fill in the details below. Once finished, you can Print to PDF (Ctrl+P) or take a screenshot to send to our team.

Part 1: Basic Project Information

Company Name		Use code name for NDA.
Contact / Title		-
Email / Tel		-
Project Name		-
Timeline	Within 6 mo. Within 1 yr. 1 yr. +	Helps plan capacity.

Part 2: Application & Regulatory (Medical Grade)

Determines facility grade and QA workflow.

Final Application		e.g. IV drip, IVD...
Body Contact?	Yes, Duration: No	Affects ISO 10993 level.
Certification	TFDA FDA CE (MDR) Other:	Chifeng is ISO 13485.
Environment	General Enclosed Room ISO Class 8 (100k)	Risk-based choice.

Part 3: Material & Sterilization Requirements

Material Preference		Or specify properties.
ISO 10993	Required Not Required	e.g. Cytotoxicity test.
Sterilization	EO Gamma Steam None	Gamma needs specific resin.
Appearance	Transparent Matte Color Code:	Medical grade colorants.

Part 4: Tooling & Production Plan

Tooling Status	New Tooling Tooling Transfer	-
EAU (Annual)	Year 1: pcs Year 2: pcs	Determines mold cavities.
Secondary Op.	2-Shot Insert Ultrasonic Laser Other:	Experience in Luer/Adapter.
Note Detail

How to Submit?

Since this form does not auto-send for security reasons, please:

1. Print to PDF: Press Ctrl + P and choose "Save as PDF".
2. Screenshot: Take a screenshot of the filled form.
3. Copy-Paste: Select all text and paste into your email.

Send to: service@e-elect.com.tw

Attn: Ms. Tsai, Project Sales Manager

Chifeng Plastics Co., Ltd. | Your Medical Molding Partner
www.chifeng-medical.com

2026-04-03

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