Regulatory and Quality Systems Solutions
for the Medical Device Industry
About Us
Consulting
510(k) EZ™
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Training
Quality Manual & Procedures
Business Friendly Results
Helpful Links
Consulting

Amica Solutions offers consulting expertise in the following areas, using a “business-friendly” approach:

Quality Systems Compliance
QSR, ISO 9000, ISO 13485
Process Improvement
CAPA and Problem-Solving
Quality Tools
Management Coaching		 483 and Warning Letter Resolution
Inspection Preparedness
Gap Analysis
Recalls
Audits
Regulatory Affairs International
FDA Registration & Listing
Premarket Notification & Approval
CE Marking & International Licensing
Medical Device Reporting & Vigilance
Enforcement Activity (483, Warning Letter)		 CE Marking
Canadian Licensing
Japanese Shonin
Other International Licenses & Registration
Import/Export
Amica Solutions
2300 McDermott Road, #200-207, Plano, TX 75025
Phone: 972-849-5167
E-mail: koakes@amicasolutions.com