Our group specializes in modifying a complete set of 21 CFR 820 processes to quickly bring organization controls into full compliance for processes including:

• 510(k) / PMA Submissions
• FDA 21 CFR Parts 11/111/210/211/803/806/820
• MDD 93/42/EEC Regulations
• Japan MHLW (厚生労働省) Regulations
• Canadian MDR Regulations
• Design Controls/QSR Audits

Taika: Our name takes its inspiration from the Taika (大化) Reforms period in Japan. This was a unique period in Japanese history where brilliant/decisive leadership centralized and strengthened governance, enabling the country to escape the burden of feudal society stuck in a cycle of perpetual conflict and war.

Centralized control promotes communication, enables cost efficiencies and returns higher quality standards. It keeps the focus on marketing and quality activities with the objectives of avoiding regulatory findings, while remediating possible process deficiences.