Peace of mind for Medical Devices and IVDR businesses.Compikal is your partner to maintain an up-to-date Quality Managment System that comply with the applicable standards and regulations for your customers and markets.

ANY TIME COMPLIANCE
Ensure continuous regulatory adherence through AI-enhanced human intelligence:
- Remote and on-site QMS assessments
- Real-time compliance verification
- Comprehensive standard coverage:
• ISO 13485
• FDA QSR 820
• ISO 14971
• IEC 62304
• IEC 60601
• EU MDR 2017/745
• IEC 62366

UP TO DATE for EXCELLENCE
Experience unmatched support for your quality management journey:
- 24/7 expert guidance at no additional cost
- Immediate responses to regulatory questions
- Continuous updates on requirements
- Proactive compliance maintenance

PRODUCTIVITY by LOW COST SOLUTION
Transform your quality management with ready-to-implement solutions:
- Complete set of Standard Operating Procedures (SOPs)
- Customizable templates for immediate deployment
- Easy adjustment to meet your specific needs
- Full compliance with key standards:
• ISO 13485
• FDA QSR 820
• ISO 14971
And other applicable regulations.

Ready to elevate your medical device quality management?
Contact us for a free consultation and discover how we can streamline your compliance journey.




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