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Medical Device Training

We design our programs to equip professionals with the skills and knowledge necessary to understand the highly regulated medical device industry.

The courses will cover basic areas from regulatory requirement to best practices for complying with international standards.

Advancement trough training

We provide:

Diverse learning methods:​

classroom-based, virtual, and blended courses

Industry-specific solutions:

tailored training for medical device manufacturers and sterilizers

Customized learning:

bespoke training solutions based on industry needs

Standard-based training:

comprehensive ISO and other standard-specific courses

Specialized subject training:

covering microbiology techniques and validation of test methods

Industry-experienced trainers:

expert trainers with years of experience in the industry
Specifies method for determining microbial contamination (bioburden) on medical devices before sterilization.

​ISO 11737-1 
Bioburden Test 

These tests identify bacterial endotoxins, ensuring safety and compliance with health standards.

<USP 161>, <USP 85> Endotoxin Testing 

Outlines method to detect microbial contamination, ensuring products meet sterility requirements.

ISO 11737-2
Sterility Testing

A standard that evaluates the amount of ethylene oxide (EO) and its by-products on medical devices after sterilization.

ISO 10993-7
EO Residual Testing

Address

SaniChem Resources (HQ) 

No. 7 & 7A, Jalan Timur 6/1A, Mercato, 71760 Bandar Baru Enstek,
Negeri Sembilan

Contact Us

+606-794 7606

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