A right-first-time approach for the journey to market
Company Size
11-200
Region
- Europe
Country
- Norway
Product
- Qualio
Tech Stack
- eQMS
- Cloud
Implementation Scale
- Enterprise-wide Deployment
Impact Metrics
- Customer Satisfaction
- Digital Expertise
- Productivity Improvements
Technology Category
- Functional Applications - Enterprise Resource Planning Systems (ERP)
- Functional Applications - Product Lifecycle Management Systems (PLM)
- Functional Applications - Remote Monitoring & Control Systems
Applicable Industries
- Healthcare & Hospitals
- Life Sciences
Applicable Functions
- Product Research & Development
- Quality Assurance
Use Cases
- Regulatory Compliance Monitoring
- Remote Patient Monitoring
Services
- System Integration
- Training
About The Customer
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.
The Challenge
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.
The Solution
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.
Operational Impact
Quantitative Benefit
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