Medical Device

Define processes, connect data and have complete control over your procedures

Maintain a centralised repository of device data

Effective quality control and regulation compliance

Reduce device time to market with effective workflow management

Medical device

Navigating the regulatory minefield of ISO 13485, ISO 14971 and FDA CFR 820 whilst developing a medical device is often the key delay in getting a product to market. Disparate documentation and product development data only ever contributes to these delays and can lead to missed revenue opportunities for medical device organisations.

Track, trace and accelerate your product development using the Opvia cloud platform. Opvia’s unique solution allows teams to connect design and quality control data by product, from requirements to inputs, outputs and associated risks. These design control data sets sit alongside the version controlled documentation needed to seek regulatory approval.

With everything under one roof, identifying problems or improvements and tracing back to their root causes becomes a rapid and seamless experience.

Medical device

Opvia is the only platform that is flexible enough to adapt to our interdisciplinary company and can later on scale up with us to manufacturing. We can seamlessly track the full lifecycle of our innovations - from a single duck egg cell to the worlds first cultured foie gras product!

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Héloïse Coutelier, PhD

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Workflows for Medical Device

Discover some of the workflows leading Medical Device companies have as part of their platform.
  • Automated Data Collection

    Connect your equipment to your process workflows and automate data processing

  • Electronic Batch Records

    Hold your processes accountable and ensure compliance. Track every step throughout your process with Opvia’s transparent and connected electronic batch record (EBR) solution.

  • Product Lifecycle Management

    Ensure digital traceability and compliant data management across your entire product development processes

  • Registries

    Create Registries and databases of Information for any entity

  • Resource and Inventory Management

    Manage resources, materials and equipment across your entire development and manufacturing process

  • Sample Management

    Never lose track of a sample and its associated data again with Opvia’s Sample tracking solution

Quality Management for Medical Device

Discover the features leading Medical Device companies use to setup their custom in-house quality system
  • 1. Document Management

    Fed up of loose, uncontrolled documents across your organisation? Are people making changes to archived SOPs? Or Is your document change control process painfully manual?

  • 2. Training Management

    Difficulty in knowing whether employees are up to date with the latest protocols or procedures? Looking for one source of truth for all training activities?

  • 3. Corrective and Preventative Actions

    Continually guide improvements in the recording and management of quality events. Rapidly increase CAPA turnaround time and transparency by tracing and connecting issues to the processes where they occurred, all in one system.

  • 4. Risk Management

    Put compliance and business assurance at the heart of your process workflows, with our integrated, fully connected risk management system

  • 5. Audit Events

    Summarise all audit relevant activity and documentation in one centralised location to ensure audit events breeze by