Aug 17, 2022
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Service categories
Domain focus
Healthcare
Other
Challenge
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.
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.
Solution
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.
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.
Results
The successful audit proved the robust definition and execution of the QMS. As a result, 7 months after project kickoff, gMendel received ISO13485 certification from LRQA.
The successful audit proved the robust definition and execution of the QMS. As a result, 7 months after project kickoff, gMendel received ISO13485 certification from LRQA.