Medical Device Consulting Services
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Quality System Installation and TrainingOur customers can benefit from the thousands of hours we have invested in quality system design and implementation. Whether it is supporting the implementation of our own quality system products or developing custom quality system procedures, our goal is to help our customers focus on their products and services while providing the resources needed to achieve ISO 13485 certification and FDA QSR compliance.
For more information regarding our ISO 13485 quality system products and services contact us at [email protected] |
FDA QSIT Audit Preparation
An FDA audit can be intimidating but with advanced planning and preparation critical areas of concern can be addressed in advance of the audit. We conduct audits of critical systems using the same techniques an FDA auditor will likely follow.
Our audit results are documented in a confidential audit report along with an action plan. We can provide support with implementing any necessary corrective actions. Audit preparedness training, facility walkthrough's, identification of the audit team and documentation review are all made part of our audit preparation.
For more information regarding our FDA Audit Preparation Service contact us at [email protected]
Our audit results are documented in a confidential audit report along with an action plan. We can provide support with implementing any necessary corrective actions. Audit preparedness training, facility walkthrough's, identification of the audit team and documentation review are all made part of our audit preparation.
For more information regarding our FDA Audit Preparation Service contact us at [email protected]
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Design and Process Validation
Whether you are developing a new product or process you can leverage our validation products and resources to support your validation effort.
Our experienced team can develop validation master plans, design and process validation protocols, manage the overall validation effort, and provide our customers the critical support needed through final report. For more information regarding our design and process validation products and service contact us at [email protected] |
RELATED LINKS
Medical Device Quality Management System BASE
Medical Device Quality Management System BASE PLUS
Medical Device Quality Management System DESIGN
Medical Device Quality Management System DESIGN PLUS
Medical Device Quality Management System MANUFACTURING
Medical Device Quality Management System MANUFACTURING PLUS
Medical Device Quality Management System BASE
Medical Device Quality Management System BASE PLUS
Medical Device Quality Management System DESIGN
Medical Device Quality Management System DESIGN PLUS
Medical Device Quality Management System MANUFACTURING
Medical Device Quality Management System MANUFACTURING PLUS