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FDA QSR, MDSAP & ISO 13485 Audit Support

We have helped hundreds of organizations achieve certification and compliance to ISO 13485, FDA’s QSR, European Medical Device Directives/Regulations, and Medical Device Single Audit Program (MDSAP).

Choose from a full range of medical device audit services

Need an audit done remotely? We can do that.

Baseline or gap assessment

Determine your current level of compliance to relevant quality requirement including FDA cGMPs, ISO 13485, and/or CMDR. We typically conduct a gap analysis before you implement your quality system to identify areas of deficiency.

Pre-assessment audits

Usually conducted 4-8 weeks prior to an official audit, pre-assessment audits occur at the end of an implementation program to identify any remaining weaknesses in a system. Consultants who were not part of the implementation team will identify gaps you need to address and offer guidance for taking effective corrective action.

FDA mock audits

Test your internal systems and personnel in preparation for an FDA inspection. By using Quality System Inspection Techniques (QSIT), Oriel STAT A MATRIX auditors can act as FDA inspectors and assess your cGMP, GLP, GCP, and QSR processes. We can also share techniques for efficiently organizing FDA audits and managing multiple inspectors.

Internal audits

Internal audits are essential to your continuous improvement process and are required by FDA, CE Marking, and other regulations. Oriel STAT A MATRIX offers internal audit services that go beyond the basics to give you higher-level management advice for improving your quality management system and business processes.

Subcontractor or supplier audits

FDA-regulated manufacturers often rely on a complex network of suppliers. A strong supplier audit program will help you manage this network with greater confidence. Oriel STAT A MATRIX’s experienced auditors can verify that your suppliers are meeting relevant requirements, and we can help you create a supplier development program to support suppliers’ corrective action and process improvement efforts.

Auditor training

For medical device professionals, we offer interactive Exemplar (formerly RABQSA)-certified Lead Auditor Training for ISO 13485, Exemplar-certified Internal Auditor Training for ISO 13485 and Internal Auditing to MDSAP training - the first and only MDSAP auditor training offering the opportunity to earn Exemplar Global’s QM-MDSAP Competency certification. Our training, presented largely through hands-on workshops, teaches you the skills you need to plan, conduct, and follow up on compliance audits, as well as how to develop an effective auditing system.

Advanced lead auditor training and implementation

Oriel STAT A MATRIX developed the world’s first performance based auditor training and consulting methodology, which raises the bar in the areas of internal and supplier audits. This innovative approach emphasizes a comprehensive approach to audit preparation and audit execution.

Classes are available as in-person or virtual instructor-led trainings. Select a course to learn more or to register.
 
Course Name Public Private
ISO 13485 Lead Auditor Training
EU MDR Auditor Training (Europe’s Medical Device Regulation 2017/745)
Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program
New!   EU IVDR Auditor Training (Europe’s In Vitro Diagnostic Regulation 2017/746)
New!   Conducting a Remote Medical Device QMS Audit
ISO 13485 Internal Auditor Training

Learn the relevant skills and knowledge you need to audit quality management systems for medical devices (QMS). Click to learn more.

Designed for experienced auditors who need to perform internal and supplier audits to the EU MDR requirements. Click to learn more.

Designed for experienced auditors, this intensive class will teach you how to apply MDASP's process-based audit approach and align your current internal audit program to the MDSAP requirements. Click to learn more.

For experienced auditors who need to perform internal and supplier audits to the EU IVDR requirements.

This class is for experienced medical device auditors who want to learn how to conduct effective remote audits. 

Exemplar Global Certified QMS Internal Auditor Training Course. Learn the steps to develop, implement, and audit an internal quality system that efficiently and effectively meets the requirements of ISO 13485 and ISO 9001. Course exercises feature audit criteria from ISO 13485:2016. Click to learn more.

Provided below are a variety of practice related white papers, market updates and case studies.

Increasing the Value of Audit Programs with Performance Based Auditing

Becoming an Effective ISO 13485:2016 Auditor 101

Get answers right now. Call 1.800.472.6477

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