Medical Device Suite Overview

Medical Device Suite is a compliance software specifically tailored to meet the stringent regulatory requirements of the medical device industry. This platform helps manufacturers ensure that their products comply with international standards such as FDA, CE, ISO, and other regulations. It offers tools for managing design controls, risk management, and documentation throughout the product lifecycle. Medical Device Suite also helps businesses track and manage quality audits, corrective actions, and customer complaints, ensuring that all compliance-related processes are streamlined and transparent. With features like automated reporting, real-time compliance tracking, and integrated document management, it ensures that companies stay up to date with regulatory changes and avoid costly compliance violations. By maintaining a high level of regulatory oversight, the software allows businesses to reduce risk, improve product safety, and ultimately enhance patient care.

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Contact Details

  • Vendor Name Knowllence
  • Founded 2001
  • Location France

Support

    NA


Training

  • NA

Licensing & Deployment

  • Proprietary Proprietary
  • Cloud Hosted Cloud Hosted
  • Web-Based Web-Based

Typical Customers

  • Self-Employed Self-Employed
  • Small-Business Small-Business
  • Midsize-Business Midsize-Business

Languages Supported

English


Industries

Accounting, Computer Software, Health, Information Technology & Services, Medical Device

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Medical Device Suite Features

  • Arrow Icon HIPAA Compliant
  • Arrow Icon Compliance Tracking
  • Arrow Icon Risk Assessment
  • Arrow Icon Environmental Compliance
  • Arrow Icon Policy Management
  • Arrow Icon Alerts/Escalation
  • Arrow Icon ISO Compliance
  • Arrow Icon Incident Management
  • Arrow Icon Risk Management
  • Arrow Icon OSHA Compliance
  • Arrow Icon Document Management
  • Arrow Icon Task Management
  • Arrow Icon Surveys & Feedback
  • Arrow Icon Training Management
  • Arrow Icon Compliance Management
  • Arrow Icon FDA Compliance
  • Arrow Icon Audit Management
  • Arrow Icon Audit Trail
  • Arrow Icon Controls Audit
  • Arrow Icon Access Controls/Permissions

Medical Device Suite Pricing

Pricing Type

  • Pricing Type Contact Vendor

Preferred Currency

  • EUR (€) EUR (€)

Free Trial

  • NA

Free Version

  • NA

Payment Frequency

  • NA

Medical Device Suite FAQs

Medical Device Suite is a compliance software specifically tailored to meet the stringent regulatory requirements of the medical device industry. This platform helps manufacturers ensure that their products comply with international standards such as FDA, CE, ISO, and other regulations. It offers tools for managing design controls, risk management, and documentation throughout the product lifecycle. Medical Device Suite also helps businesses track and manage quality audits, corrective actions, and customer complaints, ensuring that all compliance-related processes are streamlined and transparent. With features like automated reporting, real-time compliance tracking, and integrated document management, it ensures that companies stay up to date with regulatory changes and avoid costly compliance violations. By maintaining a high level of regulatory oversight, the software allows businesses to reduce risk, improve product safety, and ultimately enhance patient care.

  • No, Medical Device Suite does not offer a free version.

  • Yes, Medical Device Suite offers a free trial.

  • No, Credit Card details are not required for the Medical Device Suite trial.

  • No, Medical Device Suite does not offer an API.

  • Medical Device Suite supports the following languages:
    • English

  • Following are the typical users of the Medical Device Suite:
    • Self-Employed , Small-Business , Midsize-Business

  • Medical Device Suite supports the following deployment:
    • Cloud Hosted

  • Medical Device Suite supports the following devices and operating systems:
    • Web-Based