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Regulatory and Quality
Systems Solutions
for the Medical Device Industry |
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| Quality Manual & Procedures |
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Why reinvent the wheel? We offer essential quality system
documentation in an electronic format (Microsoft Word® compatible) that is easy
to customize to meet your company’s needs.
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Quality Systems Manual
Quality Systems Manual for ISO 9000:2000, ISO 13485, and Quality Systems
Regulation. |
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Order by E-mail Price: $200.00
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Procedures & Forms—Management
Responsibility
Includes management responsibility, training, audits, and management
review.
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Order by E-mail Price: $50.00
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Procedures & Forms—CAPA Series
Includes nonconforming material control, complaint handling, CAPA, MDR
reporting, and recalls/corrections.
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Order by E-mail Price: $100.00
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Procedures & Forms—Design Control Series
Includes design planning, design input, design output, design verification,
design validation, design review, design transfer, and design history file. |
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Order by E-mail Price: $100.00
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Procedures & Forms—Purchasing Control
Series
Includes supplier evaluation and purchasing documentation. |
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Order by E-mail Price: $50.00
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Procedures & Forms—Document
Control Series
Includes document control, change control, and quality records control. |
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Order by E-mail Price: $75.00
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Amica Solutions
2300 McDermott Road, #200-207, Plano, TX 75025
Phone: 972-849-5167
E-mail: koakes@amicasolutions.com |
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