Background
Our client is a leading multinational medical device company with a wide-ranging product portfolio that runs the gamut from lower-risk consumer products to high-risk devices. To ensure business continuity in the EU, they recognized the need to get a head start on EU MDR compliance well before the May 2020 effective date.
Planning for their transition started before the 2017 publication date and, by early 2019, they were ready to conduct internal audits at 20+ facilities throughout the US, Europe, and the Middle East. Each internal audit needed to be conducted in advance of individual site Notified Body audits.
With support from Oriel STAT A MATRIX’s EU MDR audit team, our client passed an EU MDR certification audit that encompassed five different legal anufacturers at one single site with no major nonconformances and only minimal remediation work was required.
Customer Challenge
Early on the customer recognized that their internal staff resources would not be sufficient to meet the tight timelines. They also wanted an independent assessment of each facility, so they turned to Oriel STAT A MATRIX to support them in this effort.
Oriel STAT A MATRIX Approach
Planning the program This project had to be carefully choreographed due to the “hard stop” deadlines associated with prescheduled Notified Body audits at many facilities. This included establishing a program structure that would support a hectic audit schedule yet keep the client core regulatory team well informed of progress and findings from each audit. To manage this, we kicked off the project with a full-day planning session that included the client’s core EU MDR team.
During this session we established:
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Detailed project scope
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Sites to be audited and schedule
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Number of auditors required
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Communication channels
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Nonconformance criteria
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Deadlines for each audit report
To ensure consistent communication, biweekly update calls were established for the client core team.
We also developed customized audit reports for the engagement that included:
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Internal audit overview – High-level document providing a succinct overview of critical findings by facility. This allowed client management to get a clear sense of overall site health.
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Site status overview – A more granular document that provided a status and summary assessment of each site’s readiness to withstand a Notified Body audit. It also identified common themes between sites. Selecting the audit teams Each audit was staffed based on the unique characteristics of each facility. Using our skills assessment database, we assembled a team of Oriel STAT A MATRIX auditors whose technical skills and other attributes (e.g., location, language skills, etc.) best met the needs of each facility to be audited.
Conducting the audits
Using the process approach, we evaluated the links between several critical compliance systems and prepared each site for their upcoming Notified Body audit by identifying gaps, areas of weakness, and/or opportunities for improvement. In addition to the areas shown, we also evaluated numerous clinical evaluation reports, technical document files, and risk management files.
Timeline
Audits began for all 20+ manufacturing facilities in Q2 2019 and were completed in Q1 2020. Sites were prioritized based on the timing of their prescheduled Notified Body audit, risk classification of products manufactured, condition of technical documentation, size of facility, and more. In every case, we conducted audits on schedule and well within the timeframe outlined in the original plan.
Results
Our client is one of the first medical device manufacturers in the world to undergo an EU MDR certification audit, which was conducted at their headquarters in Q4 2019. This certification audit encompassed five different legal manufacturers at one single site. They passed their certification audit with no major nonconformances and only minimal remediation work was required, thus allowing the organization to focus their efforts on preparing the remaining sites to be audited with similar success.
Why Oriel STAT A MATRIX?
The company chose Oriel STAT A MATRIX because of our:
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Extensive experience managing large-scale audit programs for multinational companies with complex organizational structures
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Deep bench of auditors located in the US and Europe
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Experience with a wide range of product types and risk classes
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Well-defined internal controls to ensure uniformity for global delivery of our services
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Suite of proven EU MDR-specific audit tools
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Proven track record of delivering meaningful audits
How We Can Help You?
If we can help this multinational medical device company take control of their EU MDR compliance efforts, we can help you too. Whether you need assistance with site audits, CER reviews, risk management, or other facets of EU MDR compliance, our team is here to help.