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You will get ISO 13485 Doc Center and QMS tailored with AI for MD & SaMD 2023 compliance
Project details
This project uniquely offers a comprehensive, end-to-end solution for establishing a Documentation Center and Quality Management System for SaMD products. Unlike standard approaches, this project is meticulously aligned with multiple regulatory frameworks, including ISO 13485 and ISO 27001. It employs a Quality by Design (QbD) approach, integrating quality into every phase of the software development lifecycle. The project is cross-functional, involving Quality Assurance, Software Development, and Quality Management teams to ensure a holistic, organization-wide quality ecosystem. It's designed for dynamic adaptability, allowing for quick updates in response to regulatory changes or technological advancements. The project also includes a robust plan for ongoing maintenance and periodic audits, ensuring sustained compliance and continuous improvement. Led by a team of industry veterans, this project aims to set a new standard in quality and compliance for SaMD products.
Project Type
Legal, Training & DevelopmentWhat's included
| Service Tiers |
Starter
$100
|
Standard
$300
|
Advanced
$1,000
|
|---|---|---|---|
| Delivery Time | 1 day | 7 days | 14 days |
Number of Revisions | 1 | 2 | 3 |
Optional add-ons
You can add these on the next page.
Additional Revision
+$50About Igor
Compliance and Quality Innovation Strategist
Rehovot, Israel - 6:22 pm local time
$100.00/hr
I'm Igor Hayfetz, with more than ten years of leadership in Compliance and Quality Innovation across the medical cannabis, medical device, and pharmaceutical industries. My expertise encompasses Good Agricultural Practices (GAP), Good Manufacturing Practices (GMP), and advanced quality management systems, making me a key player in driving product integrity beyond industry norms.
Embracing the future of quality assurance, I've enriched my skill set with the
**AI-Driven Document System Optimization and Logic Control**.
This evolving expertise in AI applications directly enhances document management and operational processes, crucial for cutting-edge quality management. Utilizing AI innovations, I tackle large data management, workflow optimization, and the precision of AI-generated content, covering the deployment of intelligent document processing (IDP) and the application of logic controls to maintain output quality. My approach not only simplifies regulatory compliance and streamlines documentation but also upholds the highest quality standards, positioning me as an essential resource for projects demanding advanced document analysis and management within the strictures of GAP, GMP, and more.
🟢 Core Expertise and Skills:
🟢 AI-Enhanced Document Management
🟢 Precision in AI-Generated Content
🟢 Intelligent Document Processing (IDP)
🟢 Advanced Data Analysis and AI Management
🟢 Efficiency in Workflow Automation
🟢 **Excellence in QA Leadership:** As a frontrunner in GAP and GMP, I elevate quality benchmarks in medical cannabis, devices, and pharmaceuticals, mastering complex regulatory environments for unparalleled compliance and product quality.
🟢 **Mastery in ISO Standards:** With proficiency in ISO 9001, ISO 13485, and ISO 27001, I deliver top-tier consultancy for compliance achievement and ongoing quality and safety enhancement.
🟢 **Regulatory Documentation Excellence:** Expert in FDA QSR and ISO standards, I produce detailed documentation and submissions to enhance processes and secure compliance across the medical and pharmaceutical sectors.
🟢 **Proactive Audit and Risk Management:** Through comprehensive audits and risk analyses, I safeguard against international standard violations, pinpointing improvement opportunities and risk reduction strategies.
🟢 **Dedicated QA & Regulatory Mentorship:** I inspire teams toward excellence and align with organizational objectives by offering in-depth training in QA, regulatory adherence, and risk management in various sectors.
Committed to pushing the boundaries of quality assurance and regulatory frameworks, I apply my knowledge to the advancement of the medical cannabis, device, and pharmaceutical industries. Fluent in English, Hebrew, and Russian, I excel in communicating sophisticated regulatory and quality principles. I invite collaboration to raise industry standards with strategic quality and compliance solutions.
Steps for completing your project
After purchasing the project, send requirements so Igor can start the project.
Delivery time starts when Igor receives requirements from you.
Igor works on your project following the steps below.
Revisions may occur after the delivery date.
Project Initiation: Define the project scope, objectives, and stakeholders.
Conduct a kick-off meeting to align all stakeholders on the project's objectives, scope, and deliverables. This will include a review of regulatory guidelines such as ISO 13485 and ISO 27001 that the SaMD product must adhere to.
Regulatory and Compliance: Review all relevant regulatory guidelines.
Perform a comprehensive review of all regulatory guidelines and standards, including ISO 13485 and ISO 27001, to set the compliance framework for the project.