A right-first-time approach for the journey to market
公司规模
11-200
地区
- Europe
国家
- Norway
产品
- Qualio
技术栈
- eQMS
- Cloud
实施规模
- Enterprise-wide Deployment
影响指标
- Customer Satisfaction
- Digital Expertise
- Productivity Improvements
技术
- 功能应用 - 企业资源规划系统 (ERP)
- 功能应用 - 产品生命周期管理系统 (PLM)
- 功能应用 - 远程监控系统
适用行业
- 医疗保健和医院
- 生命科学
适用功能
- 产品研发
- 质量保证
用例
- 监管合规监控
- 远程病人监护
服务
- 系统集成
- 培训
关于客户
InVivo Bionics is a Norwegian company bringing a hybrid software/hardware medical device to market. Their innovative pressure microsensor, less than 1mm across, sits within the bladder and relays real-time information via the cloud to help treat patients with urinary dysfunction. With the EU as their primary market objective, the InVivo team is aiming for MDR and ISO 13485 accreditation, with CE marking achieved by the end of 2024.
挑战
Founder and CEO Ingelin Clausen came from SINTEF, a contract research giant based in Trondheim, to set up InVivo Bionics in 2018. Ingelin’s experience in a highly mature, successful life science organization meant she was keen to start her new project in the strongest, most quality-centric way possible. The new InVivo Bionics team was keen to implement a system that would allow: Audit trailing and full traceability of quality data, Centralization of the entire QMS in one tool, Control of key quality areas like design controls, CAPAs and customer feedback as the company approaches marketization.
解决方案
As a holistic eQMS platform housing all quality activity in an easy-to-use interface, Qualio was selected as the best eQMS for InVivo Bionics’ plans. After a white glove onboarding and validation set-up, Qualio now provides a central quality platform accessible across the InVivo operation. Staff, consultants, and suppliers all log into Qualio to access and act on accurate, up-to-date quality information – and drive a high-quality pathway to the European market.
运营影响
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