Archive for the ‘Featured’ Category

Preparation, Review and Approval

January 27, 2010  |   Featured   |   admin  |   Comments Off

Preparation, Review and Approval

Preparation, review and approval for product registration and licensing documentation and applications including: FDA Premarket Notifications (510(k), FDA Premarket Approval Applications (PMA), Canada Device Licensing, MDD-CE Technical Files, exemption substantiation documentation.

Expertise and Preparation

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Expertise and Preparation

Expertise and preparation of required compliance documentation including Design History Files (DHF), Device Master Records (DMR), Risk Management Evaluation, Corrective Action and Preventative Action systems (CAPA), Medical Device Reporting system (MDR), Post Market Surveillance Strategies.

Microbiological Testing

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Microbiological Testing

Microbiological testing services including bioburden, sterility, disinfection efficacy, particulate analysis microbial limits, BI certification, cytotoxicity, and sterilant resistance.

Compliance and Quality Assurance

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Compliance and Quality Assurance

Compliance and Quality assurance that provides confidence with both internal and external customers.

Comprehensive Compliance Auditing

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Comprehensive Compliance Auditing

Comprehensive compliance auditing services using FDA QSR, ISO 13485, Canada MDR. Follow up and sustaining programs.

Comprehensive Laboratory Testing

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Comprehensive Laboratory Testing

Compliance Systems International along with it's strategic partners can provide comprehensive laboratory testing and analysis services.