QbD IVD | Qarad Logo - medical devices

QbD IVD | Qarad

medical devices
China's Best One-Stop Medical Equipment Provider
About

QbD IVD | Qarad is a consulting company specializing in Regulatory Affairs and Quality Systems for the In Vitro Diagnostics and Medical Device industries. Founded in 2000 and headquartered in Belgium, Qarad has expanded to Switzerland to better serve its European clients. With over 30 years of experience, the company is ISO 13485:2016 and ISO 27001:2013 certified, ensuring high standards in quality management and information security. Qarad offers a range of services, including Regulatory Affairs consulting, Quality Management System implementation, and performance evaluation for IVD devices. The company conducts clinical performance studies and provides Authorized Representative services for the EU, UK, and Swiss markets. Additionally, Qarad has developed a proprietary digital solution for electronic Instructions for Use (eIFU), facilitating the compliant distribution of technical documentation. Their expertise supports IVD and Medical Device manufacturers in achieving regulatory compliance and market access across multiple international markets.

Technologies
Amazon SES Outlook Zendesk Microsoft Azure Google Dynamic Remarketing Google Tag Manager Linkedin Marketing Solutions Hubspot Google Font API Google Analytics Nginx DoubleClick Mobile Friendly DoubleClick Conversion WordPress.org
Keywords
eifu scientific validity reports in vitro diagnostics risk management quality system implementation authorized representative online instructions for use elabeling regulatory affairs consulting training ce marking translation iso13485 performance evaluation ivd medical equipment manufacturing medical device certification clinical studies medical device regulation european market entry post-market surveillance medical devices regulatory compliance iso 27001 performance evaluation reports b2b risk management system notified body support performance evaluation regulatory stakeholder engagement
Company Information
  • Employees 27
  • Founded 2000
Location

257 Pas, Roeselare, Vlaams Gewest, Belgium, 2440

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