{"id":14321,"date":"2019-12-03T16:53:33","date_gmt":"2019-12-03T16:53:33","guid":{"rendered":"https:\/\/oxfordcorp.com\/?p=14321"},"modified":"2023-10-12T19:14:51","modified_gmt":"2023-10-12T19:14:51","slug":"gap-assessment-and-workstreams-for-mdr-compliance","status":"publish","type":"post","link":"https:\/\/www.oxfordcorp.com\/fr\/insights\/case-study\/gap-assessment-and-workstreams-for-mdr-compliance\/","title":{"rendered":"Gap Assessment and Workstreams for MDR Compliance"},"content":{"rendered":"

Discover how Oxford provided assistance to keep the project on track.<\/em><\/p>\n

INDUSTRY<\/strong>
\nMedical Device Manufacturing<\/p>\n

SERVICES<\/strong>
\nRegulatory Affairs<\/p>\n

SKILLS<\/strong>
\nEU MDR Compliance<\/p>\n

The Challenge<\/strong>
\nWhen a European medical device manufacturer needed to achieve MDR compliance, they began the process of performing a gap assessment and developing a roadmap to determine what business requirements needed to be met and how MDR compliance could be achieved. However, due to the lack of available resources within the company at the time, they were unable to carry out the complex, fast-moving project while also maintaining their day-to-day operations.<\/p>\n

The Solution<\/strong>
\nOxford Global Resources assessed the client\u2019s processes and systems to help them fill knowledge gaps and assist with the many moving parts of the project. We were able to provide four professional consultants to support the client\u2019s European MDR compliance project, which included an MDR project lead and three SMEs: one each for CERs, PMS, and technical file updates. After working with the client to complete an initial gap assessment and identify areas for improvement, these experts worked alongside internal employees and a dedicated PMO lead to quickly establish seven individual workstreams. The objectives of these workstreams consisted of:<\/p>\n

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