We provide Medical Device Consulting, U.S. Agent, CE mark, ISO, Pharmaceutical and Quality Assurance, Regulatory Consulting Services.

• 510(k) submission assistance
• FDA Trouble Shooting
  
• 483 & Warning Letter Responses
  
• Quality System Compliance
  

We provide our clients the following high-quality and high-value consulting services:

• FDA compliance – regulatory strategy development, clinical trial development/ management, on-site audits, validation (process, software and sterilization) and 510(k) submission services.
• ISO compliance – ISO 9000:2000, ISO 14000, ISO 13485:1997 (EN46001), EN540 and Quality Systems.
  
• Crisis Intervention – FDA audit response (483), warning letters, and product recalls.