{"id":14299,"date":"2019-11-12T18:52:29","date_gmt":"2019-11-12T18:52:29","guid":{"rendered":"https:\/\/oxfordcorp.com\/?p=14299"},"modified":"2023-10-13T15:32:33","modified_gmt":"2023-10-13T15:32:33","slug":"support-and-guidance-mdr-compliance","status":"publish","type":"post","link":"https:\/\/www.oxfordcorp.com\/en\/insights\/case-study\/support-and-guidance-mdr-compliance\/","title":{"rendered":"Support and Guidance for MDR Compliance"},"content":{"rendered":"

Discover how Oxford helped a medical device manufacturer start their MDR compliance journey the right way.<\/em><\/p>\n

INDUSTRY<\/strong>
\nSurgical Instruments<\/p>\n

SERVICES<\/strong>
\nEuropean Medical Device Regulations (MDR)<\/p>\n

SKILLS<\/strong>
\nRisk Mitigation & Management
\nQuality Assurance<\/p>\n

The Challenge<\/strong>
\nA medical device manufacturer of surgical tools was beginning their MDR compliance journey. As they had limited resources and knowledge of MDR, they decided to pursue outside support. Due to Oxford Global Resources\u2019 organized, hands-on approach and oversight of the project, the client felt more comfortable partnering with us.<\/p>\n

The Solution<\/strong>
\nTwo Oxford Quality Assurance Subject Matter Experts were selected to guide the client through an initial gap assessment of all product files. The consultants thoroughly reviewed all documentation including design history files and CERs to identify gaps and areas for remediation as the client moved from MDD compliance to MDR.<\/p>\n

The Result<\/strong>
\nThe consultants completed the initial gap assessment within two months. The client was able to strategically leverage Oxford\u2019s services in order to prevent interruptions in their new product launch that coincided with their EU MDR efforts.<\/p>\n

The consultants’ contract was expanded to help support enhancement and development of technical documentation for submission to the Notified Body across seven different product families, including:<\/p>\n