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A global medical device manufacturing company specializes in designing, manufacturing, and marketing advanced silicone-filled breast and body shaping implants. Its customers include physicians, hospitals, and distributors in 80 countries across the globe. While the company is based in Costa Rica it also operates offices in Brazil, Belgium, and the U.S.

While the company had a robust process for quality management process, it was still a manual system.

Essentially, this was a combination of processes that involved Microsoft Word and Excel, control folders, scanned documents, manuals, printed forms, and physical signatures to manage the process. All these processes operated in silos to make sure regulatory compliance and ISO certifications were on track.

This posed several challenges including the following:

  1. The manual system was slow and difficult to scale
  2. It didn’t support collaboration among multi-disciplinary teams when swift corrective action was needed
  3. There was no way to use data effectively to drive up quality standards and improve operational efficiency
  4. Quality-related risks were difficult to spot
  5. The various QMS processes were disconnected, making it difficult for the quality team
  6. Executive leaders did not have visibility into the quality and compliance process; Metrics were not easily accessible
  7. Overall, it was a complex set of manual processes that led to several inefficiencies

Eventually, the company decided to implement a next-generation, cloud-based EQMS from ComplianceQuest. This went live in early 2019.

After having experienced it for over three years now, the Quality Systems Manager at the company says: “I don’t know how we would have survived the pandemic if we didn’t have access to a modern, cloud-based quality management platform”.

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The ComplianceQuest EQMS turned out to be a game-changer for the Costa Rica-based company. It was designed right from the get-go to fit into the systems and procedures that the company already had.

Specifically, it helped the company with the following:

  1. Get a 360-degree view of all quality and compliance processes
  2. Ease of collaboration among a global workforce (thanks to being cloud-based and mobile-ready)
  3. Seamless integration between document, change and training modules
  4. Data visibility and transparency of quality-related information and metrics

Collaboration and data visibility were especially important during the pandemic. Supply chains were disrupted and quality leaders had to operate with agility and nimbleness to take quick decisions around new suppliers and change management efforts. Document management, new training and electronic approvals without paper-based forms were the need of the hour. With ComplianceQuest, the end-to-end quality management workflow was streamlined.

At ComplianceQuest, we’ve served 120+ medical device companies across the globe. Our product and solutions teams come with deep expertise in automation and digital transformation of quality management systems for medical device manufacturing companies. An in-depth understanding of evolving regulations and a modern, next-generation platform is crucial to connect people, processes, and systems.

With ComplianceQuest, it is easy to scale up the EQMS both for additional users and new locations. Moreover, additional functionality like CAPA Management, Risk Management, Audits, etc. can be added with ease.

Another exciting medical device manufacturing company specializing in neurostimulation technology, adopted ComplianceQuest to streamline and scale up their quality processes. The company automates the following with our platform:

  • Audit
  • Document
  • Change management
  • Complaints
  • Equipment
  • Inspection
  • Nonconformance
  • Training

To request for a demo visit: http://www.compliancequest.com/online-demo

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