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Case Studies

Multinational Medical Device Company Mitigates Business Risk Using Proactive EU MDR Compliance Audits

Our client, a global medical device manufacturer recognized they had insufficient internal resources to support timely transition to the EU MDR. They turned to Oriel STAT AMATRIX to  conduct preassessment audits to the EU MDR requiremetns. 20+ manufacturing facilities in the US, Middle East, and EU. Sites that were part of this Scope of Work passed their EU MDR certification audit with no major nonconformances and only minimal remediation work required.

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, 2021 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 2021. 

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 helps leading soft drink company save big by revitalizing their performance improvement program

A leading soft drink company was not achieving the full potential in their performance improvement efforts. Efforts were fragmented. Solutions varied from division to division and across regions preventing them from effectively connecting each business part with one another. With the support of Oriel STAT A MATRIX, the company was able to launch a global Business Process Excellence program that generated a 10-fold return on investment and earned many awards.

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