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Provide Medical Device Consulting and Regulatory Requirements Compliance Services

for ISO 13485, CE Mark and FDA Compliance for Medical Devices.

A GMP specialist will full medical device manufacturing and quality management expertise.  

 

Useful Resources:

 

A. Recommended Websites :

1.Certifcation Bodies

2. Medical Rubber, Plastics and Silicon components

3. Medical Elastomers (TPE)

4. Medical Adhesives

5. Medical Companies

 

B. Products for Sale:

 

1.       Urine Bags  

2.       Advance Wound Care   

3.       Personal Care Products 

Surgical Dressings & Swabs

4.       Orthopaedic Products  

5.       Medical  Packaging  

6.       Medical Componentries

7.    Medical Plastics

 

Special Medical Devices:  

7.   Infusion Guard

8.    Fluid Warmer

9.    EZ Flush Device

 

 

C. Consultancy Services Provided

 

 

D. Personnel

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


 

 

 

 

ISO9001

ISO 13485

CE Mark

FDA Requirements

EP Testing

Class VI

ISO 10993