Oriel STAT A MATRIX Launches Medical Device Training

Medical device manufacturers can use the courses to help compliance, identify common causes of problems, manage suppliers and more.

Oriel STAT A MATRIX announces new training courses aimed at five challenges medical device manufacturers face: complying with regulatory requirements, identifying the root causes of problems, handling complaints, managing suppliers, and controlling documentation.
To help device manufacturers meet these and other business challenges, Oriel STAT A MATRIX is constantly expanding its life sciences RA/QA training programs for new and experienced practitioners. Dr. Paul Landesman , Managing Director of Oriel STAT A MATRIX's Medical Devices and Life Sciences Practice, says: "It's all about the fundamentals. It is easier to achieve both compliance and performance excellence when a company has effective processes in place with properly trained employees."
Medical device manufacturers can choose from the following new courses:

  • Quality Systems for Medical Devices: A Comprehensive Overview of the FDA's QSR and ISO 13485 ? Learn how to create a single unified quality system that satisfies all global regulatory requirements.
  • Complaint Management: Implementing a Complaint-Handling, Safety-Reporting, and Recall Program ? Develop a comprehensive complaint-handling process from initial intake to any needed global regulatory reporting.
  • Supplier Quality Management: Designing and Implementing a Successful Program ? Get the necessary knowledge and tools to design an effective, cross-functional supplier quality program.
  • Root Cause Analysis for Medical Device, Biotech, and Pharmaceutical Investigations ? Master the full investigation process, from accurately identifying the root cause of a problem to designing an effective intervention.

In addition, Oriel STAT A MATRIX is offering a fifth, updated, course: Developing and Maintaining a Compliant Document Management System ? Find out what types of quality system documentation organizations must maintain and what level of detail auditors expect to see.
Like all Oriel STAT A MATRIX courses, these programs employ a hands-on model, including course-specific simulations and exercises, to promote active learning. Instructors keep students engaged by using a variety of formats to address all four major learning styles: visual, auditory, tactile, and kinesthetic. The training programs are available in cities throughout the United States, as well as in private, on-site sessions held at a location of your choice.
Oriel STAT A MATRIX is a global leader in consulting, training, and education related to business process improvement, regulatory compliance, and quality management systems. Areas of expertise include Six Sigma, Lean, process management, medical device and pharmaceutical quality and regulatory requirements, ISO 9000, AS9100, ISO 14000, and ISO 13485.
The firm works with a diversified client base, including corporations, governments, and institutions from every economic sector. Founded in 1968, Oriel STAT A MATRIX is headquartered in Edison, New Jersey and currently maintains offices in 18 countries.
Source: Oriel STAT A MATRIX

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