Medical Device (ISO 13485)

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Using ISO 13485:2003 as a baseline, this Gap checklist outlines what areas of your QMS need improvement to meet ISO 13485:2016.
Your Price: $59.00

ISO 13485:2003 to 13485:2016 Quality Manual Upgrade Package. Building your QMS is a cornerstone of any successful ISO 13485:2016 Registration. This fully documented ISO 13485:2003 to 13485:2016 Quality Manual that has been used for successful registrations across the globe.
Your Price: $497.00

ISO 13485:2003 to 13485:2016 Quality Manual Upgrade Instructions
Your Price: $199.00

ISO 13485:2016 Gap Analysis Checklist outlines what areas of your current Quality System need improvement to meet ISO 13485. The Gap Analysis is one of the most important steps in your project.
Your Price: $39.00

ISO 13485:2016 Forms Package. This package of ISO 13485:2016 Forms is a complete set of forms & tables to complete your ISO 13485 Quality Management System. The forms record the data to measure the effectiveness of a procedure. So every requirement will need to have a form.
Your Price: $100.00

ISO 13485:2016 procedures are designed for you to use with your ISO 13485 Quality Management System, as required by the ISO 13485 Standard. Our easy-to-customize procedures relate directly to a section of the standard with the following features: Producers list any required forms. Directly referenced by our ISO 13485 Quality Manual. Valuable in your ISO 13485 training efforts. Meets your need to attain ISO 13485 certification.
Your Price: $300.00

ISO 13485:2016 Internal Auditor Combo Package: Internal Auditor PPT Training Materials and Internal Audit Checklist Package. Train your internal audit team affordably, in-house. Clause 8.2.4 of ISO 13485:2016 requires that your organization conducts internal audits at planned intervals.
Your Price: $545.00

ISO 13485:2016 Employee Newsletters: Keep your employees informed and involved in the ISO 13485:2016 project. Employee awareness is a critical aspect of a successful project. These Newsletters improve awareness and knowledge of ISO 13485:2016 in your organization.
Your Price: $75.00

ISO 13485:2016 Quality Manual and Procedures package. Save Time, Save Money, and Simplify Certification with the RIGHT QMS!
Your Price: $397.00

ISO 13485:2016 Certification Package for Small Business; if you don’t plan to train your internal auditors, the Small Business Package is tailored especially for you.
Your Price: $697.00

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