Oriel STAT A MATRIX's in-person programming is back! Looking to advance your medical device RA/QA career? Consider taking an Oriel STAT A MATRIX class.
Check out the series below. Click on the seminar name for more information and / or to register.
Have questions?
Complete the contact form below or email info@orielstat.com.
2023 TRAINING CLASSES
- ISO 13485 Lead Auditor Training (5 days) Edison, NJ: March 27-31 | Boston, MA: April 10-14 | Washington, DC: July 10-14
Learn the relevant skills and knowledge you need to conduct and lead quality management system (QMS) audits for medical devices. Course is certified by Exemplar Global. Over 5 rigorous days, you will go through every phase of an audit, so you will be able to lead audits against the ISO 13485 standard efficiently and effectively. Who should attend: Third-party auditors, employees leading their company's QMS implementation and / or audit programs, and anyone involved in a supplier quality assurance program with auditing experience and / or has completed an internal auditor course.
- ISO 14971:2019 Medical Device Risk Management (3 days) Boston, MA: March 15-17 | Edison, NJ: May 15-17 | Washington, DC: September 6-8 | Edison, NJ: October 2-4 | Boston, MA: November 15-17
How companies manage device risk throughout the product life cycle is getting more scrutiny from regulators and Notified Bodies than ever before. Learn how to apply ISO 14971:2019 risk management from a product focus and a process focus. Who should attend: Design managers and engineers; manufacturing, service, quality assurance, reliability, research and development, and regulatory affairs professionals; and other cross-functional team members in a medical device environment. All attendees must have a basic familiarity with FDA 21 CFR Part 820 and ISO 13485.
- Quality Management Systems (QMSs) for Medical Devices: FDA QSR and ISO 13485:2016 (3 days) Washington, DC: May 31-June 2 | Boston, MA: September 11-13
This course will provide you with a solid foundation on which to build a successful career in medical device RA/QA. Through engaging classroom discussions, workshops, and activities, you will follow a product’s life cycle to explore how different elements of ISO 13485 and FDA’s QSR should be implemented at each life-cycle phase. Who should attend: Anyone who needs to understand how to meet the requirements of a global medical device quality system, including R&D or engineering managers; management representatives; product, project, and program managers; RA/QA managers/engineers; internal auditors; compliance and legal; and other cross-functional team members.
- Design Control for Medical Devices (3 days) Boston, MA: July 10-12 | Edison, NJ: September 11-13 | Washington, DC: October 2-4
Learn the process of design control – from establishing and verifying inputs to managing change. Who should attend: Anyone managing, developing, or engaging in the design of medical devices, including direct engineering functions, QA/QC, production management, and regulatory, as well as anyone else who has a role in building a robust regulatory-compliant environment. Attendees must have a basic familiarity with FDA 21 CFR Part 820 and ISO 13485.
- CAPA and Root Cause Investigation for Medical Devices (3 days) Edison, NJ: March 22-24 | Boston. MA: May 31-June 2 | Washington, DC: June 5-7 | Edison, NJ: November 6-8 | Boston, MA: November 29-December 1
This course provides a deep dive into corrective and preventive action (CAPA) systems and guides you through the entire root cause analysis process. Who should attend: Anyone in compliance/regulatory affairs, QA/QC, manufacturing operations, and document management, as well as anyone participating in root cause analysis investigations.
- Implementation of the EU MDR (3 days) Boston, MA: March 6-8
Learn about the new requirements in the EU Medical Device Regulation (MDR) and how to plan an efficient implementation. Who should attend: Medical device professionals in areas of quality and regulatory affairs, design, risk management, postmarket activities, R&D, and manufacturing, who work for manufacturers that market devices in the European Union.
