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CLINICAL TRIALS |
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| • | STUDY STRATEGY AND DESIGN |
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| • | PROTOCOL DEVELOPMENT |
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| • | PROGRAM PLACEMENT |
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| • | STUDY MONITORING |
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| • | PROGRAM MANAGEMENT |
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| • | BIOSTATISTICS |
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| • | STUDY REPORTING |
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QUALITY SYSTEMS DEVELOPMENT |
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| • | FDA QS REQUIREMENTS |
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| • | ISO 13485 |
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| • | CE MARK |
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| • | CANADA MEDICAL DEVICE LICENCE |
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PRODUCT CHARACTERIZATION |
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| • | MATERIALS AND COMPONENT TESTING AND CHARACTERIZATION |
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| • | METALS |
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| • | BIOCERAMICS |
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| • | HYDROXYAPATITE |
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| • | BIOABSORBABLE POLYMERS |
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TECHNOLOGY TRANSFER AND PARTNERSHIP |
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Areas of special expertise: |
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| • | SPINAL IMPLANTS |
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| • | ORTHOPEDIC IMPLANTS |
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| • | DENTAL IMPLANTS |
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| • | BONE GRAFT SUBSTITUTE MATERIALS |
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| • | SOFT TISSUE IMPLANTS |
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axMed International's strong technical qualifications and experience will guide you through the process of bringing your unique product to market. We offer a high-integrity approach to one of the most daunting challenges for a medical device manufacturer: regulatory product review and regulatory compliance. Our excellent and long-standing working relationship with FDA and other regulatory bodies ensures that your submissions and quality system are properly prepared and fairly reviewed. Our services include: