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<title>QMS Consulting Services | Neurophet</title><meta property="og:title" content="QMS Consulting Services | Neurophet" /><meta property="og:description" content="Neurophet QMS Consulting Services - Professional Consulting Services for establishing a Quality Management System (QMS) for Software as a Medical Device (SaMD) " /><meta property="og:image" content="<https://www.neurophet.com/assets/images/neurophetmain.png>" /><meta property="og:type" content="website" /><meta property="og:url" content="" /><meta property="og:site_name" content="neurophet.com" /><meta property="Subject" content="" /><meta property="Description" content="Neurophet QMS Consulting Services - Professional Consulting Services for establishing a Quality Management System (QMS) for Software as a Medical Device (SaMD)" /><meta property="Keywords" content="뉴로핏, 의료 인공지능, 의료 영상, 뇌 영상, 뇌 분할, 세그멘테이션, 전자약, 디지털치료제, 디지털치료기기, 뉴로모듈레이션, 치매, 알츠하이머, 인지장애, 우울증, 치매 치료제, 알츠하이머 치료제, 뇌출혈, neurophet, medical AI, medical imaging, brain image, segmentation, electroceuticals, digital therapeutics, digital treatment device, neuromodulation, dementia, Alzheimer, cognitive disorder, depression, dementia medicine, Alzheimer’s medicine, brain hemorrhage" /><meta property="robots" content="All" /><meta property="Date" content="Mon,25 Jan" /><meta property="Author" content="뉴로핏" /><meta property="Publisher" content="뉴로핏" /><meta property="Reply-To" content="" /><meta property="Email" content="" /><meta property="Copyright" content="copyright@neurophet" /><meta property="Last-Modified" content="Fri,2 Jul 2021 11:10:30" /><meta property="Build" content="Mon,28 Jun 2021 11:10:30" />
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QMS Consulting Services
</p>
<p class="lead text-white-70 mb-8">Professional Consulting Services for establishing a Quality Management System (QMS)<br> for Software as a Medical Device (SaMD)</p>
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We create better medical software through the establishment of Innovative SaMD QMS.
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class="col-lg-12 px-2 px-lg-3 mb-3 mb-lg-0 aos-init aos-animate"
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<Div class="text-white mb-4 m-6">
Neurophet provides professional consulting services for establishing a SaMD QMS.
</div>
<Div class="text-white mb-4 m-6">
SaMD is medical software that supports patient diagnosis, treatment, and monitoring, and requires high levels of safety and reliability.
</div>
<Div class="text-white mb-4 m-6">
Our quality consulting services ensure compliance with international standards and regulatory requirements crucial for SaMD development and management, while establishing an optimal QMS to support customers' product success in the market.
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<h4 class="text-white-70 font-poppins"> Features</h4>
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<div class="col-lg-12 mb-8 px-0">
<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%2F405eaf60-1211-4c34-bf20-336e0ddc9a23%2FGroup_231.png?table=block&id=4206714b-63c3-45a7-a27a-f08298998b54&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"
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<h4 class=" font-weight-bold text-white-50 ">1</h4>
<h3 class=" font-size-2-ml font-weight-bold text-white mb-2">Current State <Br>Analysis and <Br>GAP Analysis <Br><Br>
</h3>
<p class="text-white">
We assess the current status of the operating system and analyze any discrepancies against international standards such as ISO 13485 and IEC 62304, as well as regulatory requirements.
</p>
</div>
</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 ">2</h4>
<h3 class=" font-size-2-ml font-weight-bold text-white mb-2">QMS Strategy <br> and Roadmap <br> Development <Br><Br>
</h3>
<p class="text-white">
We develop a customized QMS strategy aligned with the client's business objectives and product characteristics and provide a phased plan of execution.
</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">Documentation <Br> and Procedure <Br> Establishment <Br><Br>
</h3>
<p class="text-white">
We create essential documents for SaMD QMS, encompassing Quality Manual, Procedures, Work Instructions, and Templates to enhance operational exellence.
</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">Education and <Br>Training Programs <Br><Br><Br>
</h3>
<p class="text-white">
We offer education programs for all employees to ensure effective operation of the quality management system and support training for continuous improvement.
</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 ">5</h4>
<h3 class=" font-size-2-ml font-weight-bold text-white mb-2">Internal Audit <br> and Certification <br>Preparation <Br><Br>
</h3>
<p class="text-white">
We inspect the operational status of the QMS and perform mock audits to support the acquisition of certification.
</p>
</div>
</div>
</div>
</div>
</div>
</div>
</div>
</div>
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<h4 class="text-white-70 font-poppins"> Our Expertise</h4>
</div>
<div class="col-lg-12 px-0">
<div
class="card gradient-y-overlay-sm-navy-300 mb-4"
style="
background-color: #292b3f;
background-clip: border-box;
box-shadow: 0px 12px 15px rgb(0, 0, 0, 10%);
height: autopx;
"
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<div class="card-body">
<div
class="row p-3 justify-content-between align-items-center text-left text-md-left"
>
<div class="col-lg-11 col-md-9 col-sm-12 col-12">
<p class="px-0 font-size-2-l text-white font-weight-bold mb-3">
Expertise
</p>
</div>
<div class="col-lg-11">
<p class="col-lg-12 p-0 font-size-2-s text-white-70">
Our consultants, with over 15 years of experience in the field of SaMD and medical devices, bring a wealth of expertise to our consulting services.
</p>
</div>
</div>
</div>
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<div
class="card gradient-y-overlay-sm-navy-300 mb-4"
style="
background-color: #292b3f;
background-clip: border-box;
box-shadow: 0px 12px 15px rgb(0, 0, 0, 10%);
height: autopx;
"
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<div class="card-body">
<div
class="row p-3 justify-content-between align-items-center text-left text-md-left"
>
<div class="col-lg-11 col-md-9 col-sm-12 col-12">
<p class="px-0 font-size-2-l text-white font-weight-bold mb-3">
Customized Service
</p>
</div>
<div class="col-lg-11">
<p class="col-lg-12 p-0 font-size-2-s text-white-70">
We provide personalized consulting services tailored to the characteristics and requirements of each client.
</p>
</div>
</div>
</div>
</div>
<div
class="card gradient-y-overlay-sm-navy-300 mb-4"
style="
background-color: #292b3f;
background-clip: border-box;
box-shadow: 0px 12px 15px rgb(0, 0, 0, 10%);
height: autopx;
"
>
<div class="card-body">
<div
class="row p-3 justify-content-between align-items-center text-left text-md-left"
>
<div class="col-lg-11 col-md-9 col-sm-12 col-12">
<p class="px-0 font-size-2-l text-white font-weight-bold mb-3">
Keeping Up with Regulatory Trends
</p>
</div>
<div class="col-lg-11">
<p class="col-lg-12 p-0 font-size-2-s text-white-70">
We ensure that our services reflect the latest international standards and regulatory trends, enabling clients to maintain up-to-date QMS at all times.
</p>
</div>
</div>
</div>
</div>
<div class="space-top-3 w-md-100 text-center mx-auto mb-10">
<p class="display-4-xxs w-xl-80 w-lg-60 w-sm-80 w-80 text-white font-weight-bold mb-2 text-center mx-auto">
Understanding of Medical Device QMS
</p>
</div>
<div class="col-lg-12 mb-8 px-0">
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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%2F68ec3ca7-72bc-446a-a82f-da6d6d449ba8%2FFrame_76_(2).png?table=block&id=291f494d-b1c3-479e-b013-cd4d23d9adac&spaceId=9453ab34-9a3e-45a8-a6b2-ec7f1cefbd7f&width=2000&userId=&cache=v2>"
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