CASE STUDY

Start-up venture achieves Class I CE status just 6 months from prototype

In 6 months

Class I CE status achieved

The start-up venture partnered with us to achieve Class I CE Status just 6 months after prototype and secure funding from investors for their breakthrough non-invasive microcirculation technology.

Outcome

Accelerated self-certification: Expedited self-certification process to achieve Class ICE status first time and within 6 months from prototype.

Scalability: A scalable QMS system and a fuss-free way to present evidence to notified bodies.

Reduced costs: Successfully met deadlines in an approves market-ready product with minimal costs.

Secured funding:: Secured a further round fo funding and opened up the opportunity to make sales.

Challenges

  • Aligning regulatory & commercial strategy
  • Being first to market
  • Navigating compliance requirements
  • Scaling regulatory plan

About this start-up venture

This start-up venture’s breakthrough technology assesses microcirculation with non-invasive technology, enabling tailored therapy to be given to patients and complications to be detected early on – potentially saving countless lives.

Location: Norway

Company size: Start-up venture 10+ employees

Industry: Medical

AND were extremely supportive specifically on software life-cycle management, which they are experts on.

Quality Manager, Start-up Venture

Approach

Strategy development

Acted as an independent verification and validation partner, consulting the plan for navigating through regulatory hurdles

Workshops

Undertook workshops with senior management to devise a plan that aligned with commercial strategy

Action

Conducted code and design reviews, testing, QMS documentation handling, and oversight of self-certification Class I CE

Software expertise

Presented software expertise to support MDD andMDR transition resulting in progress towards Class II device.

Potential for non-invasive microcirculation technology to save countless lives

Over the last decade, it has become clear how important assessing the microcirculation function is. Microcirculation is fundamental in delivering oxygen and nutrients to all living tissues in our body. If neglected, complications to microcirculation can lead to cardiovascular and metabolic diseases, such as coronary artery disease, hypertension, and diabetes, to name a few. Therefore, being able to assess complications to microcirculation, monitor the efficacy of treatment, and assess the patient’s recovery without the patient undergoing surgery, could save patient morbidity but also expensive care in ICU.

Built on 30 years of clinical research, this start-up venture has developed a novel technology to monitor microcirculation. By assessing microcirculation with non-invasive technology, tailored therapy can be given to patients. This breakthrough technology could enable complications to be detected early on, as well as see if a patient is responding to well to treatment or recovery.

I would not hesitate to use AND again should one of my device manufacturers need support, guidance, testing of software within their medical device.

Senior Director, Start-up Venture Company

Working with ODI Medical was a constructive and rewarding experience. We hope to work with ODI on more life-saving technology in the future.

Nicola Thorn, CEO, AND Technology Research

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