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Case Studies

A Proactive Approach to EU MDR Compliance Audits Pays Off

Our client, a leading multinational medical device company with a wide-ranging product portfolio, needed to get a head start on EU MDR compliance but recognized that their internal staff resources would not be sufficient to meet the tight timelines necessary to ensure business continuity. They turned to Oriel STAT A MATRIX to conduct compliance audits at 20+ global facilties. Result: No major nonconformances and only minimal remediation work required at the facilites that were part of the scope of work.

Clearing the Path to EU MDR Compliance

Our US-based client, like thousands of other medical device companies, realized they had to act soon to be fully compliant to the EU MDR well before the May 25, 2020 deadline. The organization needed to understand the EU MDR changes, the impact those changes would have on their processes, and how this would affect their day-to-day activities. With the support of Oriel STAT A MATRIX this manufacturer developed a clear plan for addressing all aspects of the EU MDR well in advance of May 2020. 

Customized CAPA Training Addresses 483 Findings for a Medical Device Manufacturer

Under the guidance of Oriel STAT A MATRIX’s regulatory experts, our customer developed a company-wide CAPA program that addressed FDA concerns and resulted in a stronger, more effective global CAPA program.

Training + Coaching = Risk Management Success

Our customer, a medical device manufacturer, faced an industry-wide challenge: assemble isolated risk management activities into a comprehensive approach that made sense for the business. With the help of Oriel STAT A MATRIX, this customer’s in-house team learned how to build a systematic, dynamic risk management process and risk management files. 

What happens when your VP of RA/QA leaves on short notice?
Oriel STAT A MATRIX to the rescue!

A contract manufacturer of medical devices urgently needed to fill a critical gap left by the resignation of its VP of RA/QA. Complicating the situation: The manufacturer was addressing an FDA Form 483 that required weekly progress reports on the mitigation plan.

Medical Device Manufacturer Untangles Supply Chain Issues and Addresses FDA Concerns with Help from Oriel STAT A MATRIX

Our customer, a manufacturer of Class II and Class III medical devices, received an FDA 483 finding that cited a weak Supplier Management system. The company was aware of this issue, but it did not have the internal resources to develop and implement the necessary corrective action.

Improve Your Quality Culture, Improve Your Results

By addressing its Quality Culture, our customer, a global medical device manufacturer, was able to address FDA and Notified Body concerns as well as improve overall employee satisfaction and business results.

Oriel STAT A MATRIX Provides Rehab for a Physical Therapy Products Company Cited by the U.S. Food and Drug Administration (FDA)

Oriel STAT A MATRIX helps to develop and implement an effective action plan that both rectified the violations and established sustainable changes that addressed the FDA’s concerns and enhanced the overall business quality functions.

Lean Six Sigma deployment at specialty pharmaceutical and medical device company pays dividends

Oriel STAT A MATRIX helps a specialty pharmaceutical and medical device company effectively implement a Six Sigma program that can rapidly identify cost savings without compromising customer service or jeopardizing FDA compliance.

Oriel STAT A MATRIX facilitates identification and implementation of life-saving changes at a major Middle Eastern hospital

Our customer, a major hospital chain in the Arabian Gulf, was experiencing a high rate of isolation intensive care unit (ICU) stays due to the spread of multidrug-resistant organisms (MDROs). There had been many ideas over a two-year period to stem the rising tide of patients being admitted to the ICU, but nothing had made a substantial difference. An Oriel STAT A MATRIX senior facilitator led a team of hospital staff to address this key problem, and they identified a number of potential causes. The team then used a Lean healthcare approach and pinpointed one issue that, if addressed, could reduce the problem substantially. By focusing on this issue, the hospital was able to save over $1M in annual unnecessary costs.

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