Case Studies A right-first-time approach for the journey to market

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	A right-first-time approach for the journey to market

A right-first-time approach for the journey to market

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
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. Read More
About 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. Read More
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. Read More Log in to view content
Contents

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

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.

About 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.

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.

Impact #1	The InVivo Bionics team has clustered around a single source of quality truth for their journey to market.
Impact #2	Strong design control management: Chief Technology Officer Daniel Aragao works closely with InVivo's product engineering team and with medical subject matter experts within Qualio's Design Controls area.
Impact #3	Collaborative quality: Qualio knits together the InVivo operation to strengthen and accelerate the route to market. Documents are written, reviewed, and circulated by the quality team to produce a core of relevant, appropriate information.

Impact #1

The InVivo Bionics team has clustered around a single source of quality truth for their journey to market.

Impact #2

Strong design control management: Chief Technology Officer Daniel Aragao works closely with InVivo's product engineering team and with medical subject matter experts within Qualio's Design Controls area.

Impact #3

Collaborative quality: Qualio knits together the InVivo operation to strengthen and accelerate the route to market. Documents are written, reviewed, and circulated by the quality team to produce a core of relevant, appropriate information.

Benefit #1	2x Speed to market
Benefit #2	100% Company engagement with Qualio
Benefit #3	1x FTE Spend mitigated by Qualio

Benefit #1

2x Speed to market

Benefit #2

100% Company engagement with Qualio

Benefit #3

1x FTE Spend mitigated by Qualio

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Overview

A right-first-time approach for the journey to market

Operational Impact

Quantitative Benefit