TransPerfect Medical Device Solutions (MDS), the world’s largest provider of language services and process automation technology to the medical device industry, announced the successful completion of a stringent supplier requalification audit for industry heavyweight Johnson & Johnson (J&J), with zero findings across the three evaluated categories: critical, major, and minor.
The scope of the J&J audit comprised nine different J&J medical device and pharma franchises and 31 different TransPerfect sites, including three primary sites for TransPerfect Medical Device Solutions. The extensive three-day audit reviewed processes and records for critical service functions, such as quality management systems (including CAPA), training records, linguist onboarding and training, and others.
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The results of the J&J audit serve as a testament to TransPerfect‘s ongoing dedication to delivering quality and automation for medical device manufacturers. TransPerfect MDS President Marc Miller observed, “J&J was among the first major device makers to run an RFP specifically for the EU Medical Device Regulation (MDR)—and we were honored to be selected as the lead supplier at the time. These audit results show that TransPerfect and J&J are aligned to move forward with services and automation technologies as we enter the next phase of MDR readiness.”
TransPerfect MDS helps manufacturers meet daunting MDR/IVDR content challenges for labeling and post-market surveillance with structured content, process automation, and AI. The division’s EnCompass solution for SSCP/SSP and labeling content can be implemented as a flexible subscription service or as a fully licensed application tailored to address specific documentation requirements.
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Innovations for the medical device industry introduced by TransPerfect include cost-saving and time-saving translation management and process automation technology, including an AI portal for MDR and IVDR post-market surveillance to simplify the translation of PMS data. Compatible with 30+ file formats, including scanned images and PDFs, the portal supports more than 40 languages and helps manufacturers manage the increased volumes and faster turnarounds required under MDR and IVDR.
TransPerfect President and CEO Phil Shawe stated, “At the end of the day, quality means everything in our industry. J&J‘s audit thoroughness makes us strive to be a better partner on many levels. We’re pleased to have exceeded their exacting standards.”
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