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품질경영시스템 컨설팅
</p>
<p class="lead text-white-70 mb-8">SaMD 품질경영시스템(QMS) 구축을 위한 전문 컨설팅 서비스</p>
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혁신적인 SaMD 품질경영시스템(QMS) 구축으로 더 나은 의료 소프트웨어를 만듭니다.
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style="
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height: 100%;
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<div class="card-body font-size-2-m" ">
<Div class="text-white mb-4 m-6">
뉴로핏은 SaMD(Software as a Medical Device) 품질경영시스템(QMS) 구축을 위한 전문 컨설팅 서비스를 제공합니다.
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SaMD는 환자의 진단, 치료 및 모니터링을 지원하는 의료 소프트웨어로, 높은 안전성과 신뢰성이 요구됩니다.
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뉴로핏 품질경영시스템 컨설팅 서비스는 SaMD 개발 및 관리에 필요한 국제 표준 및 규제 요구사항을 준수하며, 최적의 품질경영시스템을 구축하여 고객의 제품이 시장에서 성공할 수 있도록 지원합니다.
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<h4 class="text-white-70 font-poppins"> Features</h4>
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<img
class="img-fluid"
src="<https://neurophethr.notion.site/image/https%3A%2F%2Fprod-files-secure.s3.us-west-2.amazonaws.com%2F9453ab34-9a3e-45a8-a6b2-ec7f1cefbd7f%2F74bca277-0e1c-4e43-b1fc-5a0a20c004b4%2FGroup_204_(4).png?table=block&id=de86d142-ea17-447b-817f-60b106be28b8&spaceId=9453ab34-9a3e-45a8-a6b2-ec7f1cefbd7f&width=2000&userId=&cache=v2>"
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<h4 class="text-white-70 font-poppins"> Services</h4>
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class="card"
style="
background-color: #292b3f;
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<div class="card-body">
<div class="p-3">
<div class="px-0">
<h4 class=" font-weight-bold text-white-50 ">1</h4>
<h3 class=" font-size-2-ml font-weight-bold text-white mb-2">현 상태 분석 및<br> GAP 분석 <Br><Br>
</h3>
<p class="text-white">
현재 운영 중인 시스템의 현황을 평가하고, 국제 표준(ISO 13485, IEC 62304 등) 및 규제 요구사항과의 차이를 분석합니다.
</p>
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<div
class="card"
style="
background-color: #292b3f;
background-clip: border-box;
box-shadow: 0px 12px 15px rgb(0, 0, 0, 10%);
height: 100%;
"
>
<div class="card-body">
<div class="p-3">
<div class="px-0">
<h4 class=" font-weight-bold text-white-50 ">2</h4>
<h3 class=" font-size-2-ml font-weight-bold text-white mb-2">QMS 전략 및<br> 로드맵 수립 <Br><Br>
</h3>
<p class="text-white">
고객사의 비즈니스 목표와 제품 특성에 맞춘 맞춤형 QMS 전략을 수립하고, 단계별 실행 계획을 제시합니다.
</p>
</div>
</div>
</div>
</div>
</div>
<div class="col-lg-4 mb-6 aos-init aos-animate" data-aos="fade-up">
<div
class="card"
style="
background-color: #292b3f;
background-clip: border-box;
box-shadow: 0px 12px 15px rgb(0, 0, 0, 10%);
height: 100%;
"
>
<div class="card-body">
<div class="p-3">
<div class="px-0">
<h4 class=" font-weight-bold text-white-50 ">3</h4>
<h3 class=" font-size-2-ml font-weight-bold text-white mb-2">문서화 및<br> 프로세스 구축 <Br><Br>
</h3>
<p class="text-white">
SaMD QMS의 핵심 문서(품질 매뉴얼, 절차서, 작업지침 등)를 작성하고, 표준화된 프로세스를 설계하여 운영 효율성을 극대화합니다.
</p>
</div>
</div>
</div>
</div>
</div>
<div class="col-lg-4 mb-6 aos-init aos-animate" data-aos="fade-up">
<div
class="card"
style="
background-color: #292b3f;
background-clip: border-box;
box-shadow: 0px 12px 15px rgb(0, 0, 0, 10%);
height: 100%;
"
>
<div class="card-body">
<div class="p-3">
<div class="px-0">
<h4 class=" font-weight-bold text-white-50 ">4</h4>
<h3 class=" font-size-2-ml font-weight-bold text-white mb-2">교육 및 훈련<br> 프로그램 <Br><Br>
</h3>
<p class="text-white">
품질경영시스템의 효과적인 운영을 위해 전 직원 대상 교육 프로그램을 제공하고, 지속적인 개선을 위한 훈련을 지원합니다.
</p>
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</div>
</div>
</div>
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<div class="col-lg-4 mb-6 aos-init aos-animate" data-aos="fade-up">
<div
class="card"
style="
background-color: #292b3f;
background-clip: border-box;
box-shadow: 0px 12px 15px rgb(0, 0, 0, 10%);
height: 100%;
"
>
<div class="card-body">
<div class="p-3">
<div class="px-0">
<h4 class=" font-weight-bold text-white-50 ">5</h4>
<h3 class=" font-size-2-ml font-weight-bold text-white mb-2">내부 감사 및<br> 인증 준비 <Br><Br>
</h3>
<p class="text-white">
QMS의 운영 상태를 점검하고, 인증 기관의 심사에 대비한 모의 감사를 수행하여 인증 획득을 지원합니다.
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