Tangene Group LLC

Consulting to the Medical Device, Pharmaceutical, Biotech,  Biologics and Herbal Supplement.  

 Expert in

• 510(k), CE Marking, PMA, Health Canada submissions

• Quality Assurance.

• 21 CFR 820, 21 CFR 210/211, 21 CFR 111 and ISO 13485 Quality System Implementation.

• FDA, EMEA, EU, JPAL, TGA Compliance.

• Chemistry, Manufacturing and Control.

• Process Validation and method validation

• ISO 14971 Risk Management 
  
• Medical Device Technology Transfer to CMO

• FDA 483 and warning letter remediation

Call Us Today For A Free Consultation!

If you have any issues with

• FDA 483 or warning letter
• 510(k) and PMA Submission
• Quality System Implementation
• Process Validation
• Analytical Method Validation
• Risk Management