Streamlining gMendel’s regulatory journey to deliver groundbreaking MedTech

Overview

gMendel® is a Danish start-up aiming to transform the diagnosis of rare/genetic disorders (GDs) for better disease management.

gMendel technology combines Genomics, AI/Machine Learning & Blockchain, resulting in a real-time, reliable offering that can be made available widely at a low cost, ensuring the highest security & patient data encryption. At the same time, it provides a shorter, safer & economical path to accurate diagnosis of GDs. 

In this case study, we share our joint story of defining and certifying gMendel’s QMS to accelerate their route to market.

Idea

gMendel reached out to our HealthTech Practice to expedite their regulated MedTech product development journey. They partnered with us to harness our regulatory, product management, design and engineering expertise to secure QMS (Quality Management System) certification, build a foundation for investor support and start improving more lives. 

Their goals included: 

1. Defining and certifying its QMS to be compliant with both ISO 13485 and EU 2017/746 In Vitro Diagnostic Regulation (IVDR).
2. Executing Product Life Cycle management activities under its QMS to assist in the CE marking approval process for its product Phivea®, a comprehensive decision support software for healthcare professionals that allows for timely diagnosis of genetic disorders and real-time prediction of clinical interventions.
3. Developing IEC 62304-compliant, Class B medical device software.
4. Placing the product on the Danish and EU markets.

Project

Collaboration with Star’s Regulatory Consulting Practice began on July 1, 2021 using Star’s ins2outs platform as both a Quality Management System and Product Lifecycle Management System. 

On July 2, Star delivered a full ISO13485, ISO14971, IVDR know-how set to gMendel’s ins2outs account. Our QMaaS (Quality Manager-as-a-Solution) expert customized their know-how set content to gMendel’s requirements. The know-how set contained all policies, processes, procedures and other QMS documentation necessary for gMendel’s QMS. Simultaneously, our QMaaS consultant provided essential support to the gMendel® organization over the next couple of months by adjusting the QMS definition to gMendel’s business reality.

Concurrently, our Regulatory Consulting Practice worked with them on the following PLC (Product Life Cycle) documents and activities:

• The intended purpose statement for Phivea®
• Regulatory strategy linked to conformity assessment procedures 
• The Performance Evaluation Plan including DNA sampling, and the roadmap for executing performance studies
• Technical Documentation required by the IVD/IVDR regulations 
• IVD’s General Safety and Performance Requirements Analysis as mandated by Annex I
• Hazards analysis
• Risk Management, Risk Assessment and Risk Benefit Analysis plans
• Product Requirements derived from risk control measures

After the first month, we had defined gMendel’s QMS, enabling us to officially begin the Design and Development phase from the Design Start milestone. Customization of gMendel’s QMS finished three months after collaboration began. 

Simultaneously, our regulatory consultants worked with gMendel’s Product Team on the approach to product management, verification and validation strategy, configuration management, post-market surveillance and planning for performance evaluation activities. This enabled the PLC team to manage the Phivea® platform when it arrived on the market. 

gMendel selected LRQA Nederland B.V as the Notified Body for certification audit of their QMS. 

The successful audit proved the robust definition and execution of the QMS. As a result, 7 months after project kickoff, gMendel received ISO 13485 certification from LRQA. 

Star insights

On your MedTech and digital healthcare innovation journey, consider these essential regulatory and engineering lessons from our ongoing work with gMendel: 

1. An organization can significantly shorten the time to define and certify a QMS using a combination of Star’s ins2outs platform, ISO 13485 know-how sets and a Quality-Manager-as-a-Service offering. With these tools, QMS certification can be achieved in about 7 months. 
2. It is crucial to bring all stakeholders into product lifecycle management to design, develop and put an IVD medical device on the market. 
3. Regulatory consulting on Product Life Cycle management resulted in vast know-how transfer to the gMendel product team, accelerating organizational maturity in the MedTech and digital healthcare domains.