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Consulting & Auditing

Quality System Audits for ISO 13485, FDA QSR, MDSAP

Quality system audits for ISO 13485, US FDA QSR, EU MDR, MDSAP, and more. Move beyond conformance and achieve improved business results! 



Medical device companies must comply with demanding quality standards and regulations, such as ISO 9001, ISO 13485, MDSAP, and FDA’s QSR. Noncompliance with these requirements can impact the effectiveness of your processes, affect the quality of your products, and lead to the loss of certification or even a product recall.

Routine audits are required to ensure ongoing compliance to the requirements. Too often, however, routine audits only address compliance and fail to examine the company’s processes and their interactions. When nonconformances are identified, the audits focus narrowly on a specific correction without considering the systemic impact of the issue or the correction. Over time, organizations can find themselves with compliant yet ineffective quality systems.  

Need an audit done remotely? We can do that.

Move beyond conformance with an Oriel STAT A MATRIX audit

An Oriel STAT A MATRIX quality management system (QMS) audit goes beyond surface findings to examine process interactions and efficiency. Our team of experienced auditors – averaging 25+ years of international and domestic life sciences industry experience – will uncover both compliance gaps and how well your processes (and those of your suppliers) perform. This approach gives your company the information it needs to improve overall performance.

Key Advantage

Oriel STAT A MATRIX is a consulting company, not a certification or regulatory body, so our consultants can provide advice on how to remedy nonconformances.

Access our audit expertise for:

Training Courses

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 Course
EU MDR Auditor Training Course (Europe’s Medical Device Regulation 2017/745)
Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program
EU IVDR Auditor Training
ISO 9001 Lead Auditor Training
Inspection and Audit Readiness Training for Medical Device Manufacturers
ISO 9001:2015 Internal Auditor Training
Conducting Remote Medical Device QMS Audit Training
Medical Device Single Audit Program (MDSAP) Training: Preparing for a Successful Implementation
ISO 13485 Internal Auditor Training
Performance-Based Auditing for Medical Devices - A Tool for FDA’s Case for Quality

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 MDSAP'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.

Our ISO 9001 Exemplar Global-certified auditor/lead auditor training course, presented largely through hands-on workshops, teaches you the skills you need to plan, conduct, and follow-up on ISO 9001 compliance audits. Click to learn more.

Learn how to effectively set up a front room/back room audit approach so you are ready for FDA and NB audits/inspections.

Understand the steps in developing, implementing, and auditing an internal quality system that meets the requirements of ISO 9001 and the needs of your organization. Click to learn more.

Learn how to audit effectively in a remote context us1/ing Information and Communication Technology.  For experienced auditors.

Unique to MDSAP audits are a process-based audit approach and use of a nonconformity grading matrix. Understanding these two critical components of MDSAP is key to a successful certification audit, and this course covers both in depth. Click to learn more.

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.

Designed for experienced auditors. Course participants learn how to go beyond compliance and analyze the performance-related data needed to improve processes, produce higher-quality devices, and achieve better patient outcomes.

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

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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