ABOUT US
Lis Quality Consulting company specializes in consulting.
At Lis Quality Consulting we are a trusted partner in navigating the intricate realm of quality and regulatory compliance. With a team of seasoned experts and a proven track record of success, we specialize in providing comprehensive consulting services to organizations across industries. From startups to established enterprises, we offer tailored solutions to meet the unique needs and challenges of each client.
Our commitment to excellence is at the heart of everything we do. We work closely with our clients to understand their goals, challenges, and aspirations, offering strategic guidance and practical support every step of the way. Whether it’s ensuring compliance with regulatory requirements, optimizing quality management systems, or preparing for market entry, we are dedicated to delivering results that exceed expectations.At Lis Quality Consulting we pride ourselves on our deep industry knowledge, technical expertise, and unwavering dedication to customer satisfaction. We believe in fostering long-term partnerships built on trust, integrity, and mutual success. With our proactive approach and personalized service, we strive to empower our clients to achieve their regulatory and quality objectives, enabling them to thrive in today’s competitive marketplace.Experience the difference of working with a trusted advisor committed to your success. Partner with Lis Quality Consulting and unlock the full potential of your organization.
- Trusted partner in quality and regulatory compliance consulting
- Tailored solutions for organizations across industries
- Deep industry knowledge, technical expertise, and proactive support
- Commitment to customer satisfaction and long-term success
Project Done
Quality Systems
Years of experience
Training and qualifications
Our consulting team, comprised of industry professionals, stays consistently updated with the latest developments in global requirements and standards.
The ultimate goal is to provide services at the highest level and meet the evolving requirements of our businesses. We focus on quality and innovation.
OUR SERVICES
Unlock Your Business with Consulting Services
Our company offers a personalized and unique service tailored to each client, whether they are small startups or leading giants
510k
We provide 510k Medical Device (MD) consulting services to medical device companies in Israel. Our services are available for specific projects or individual
CE marking
We are ready to fully support your CE Marking transition from the Medical Devices Directive (MDD) to the Medical Devices Regulation (MDR).
ISO 13485 and ISO 9001
Quality Management System (QMS) Compliance We make sure a QMS that your Company meets the QMS specifications and requirements through
Auditing
Audits are executed to determine regulatory compliance and improve effectivity of your processes and those of your critical subcontractors and suppliers
Sterilization Validation / Microbiology
Sterilization validation and microbiological control are crucial for ensuring medical device safety and preventing infections.
Microbiology Process Evaluation
Environmental control is crucial for GMP, with ongoing monitoring essential for effective microbiological control
Business Strategy
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Financial Consulting
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Marketing & Branding
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Information Technology
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Operations & Supply Chain
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Sales & Development
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VISION & MISSION
Experience Benefits of Professional Consulting
Vision
Our vision is to become the foremost trusted partner for organizations worldwide in achieving excellence through unparalleled Quality & Regulatory management solutions. We envision a future where every business operates at its highest potential, driven by a culture of quality, efficiency, and continuous improvement.
Mission
Our mission is to empower organizations to thrive by delivering comprehensive Quality & Regulatory consulting services tailored to their unique needs. Through expert guidance, innovative strategies, and relentless dedication, we assist our clients in enhancing their processes, products, and services, ultimately fostering sustainable growth, customer satisfaction, and market leadership.
LIS
What Client Says About LIS
- A.N.G.S Systems Ltd.
- Sniff logic
- Med-op Aesthetic
Frequently Asked Question
You ask, we answer, some of the frequently asked questions we receive.
What is the quality certification process, and why is it important?
The quality certification process involves assessing and ensuring that products, processes, or systems meet specified quality standards. It’s important as it helps organizations demonstrate their commitment to quality, customer satisfaction, and continuous improvement.
What are the steps involved in the quality certification process?
The steps typically include defining quality objectives, establishing quality management systems, conducting internal audits, undergoing external audits by certification bodies, addressing non-conformities, and achieving certification.
Who conducts quality certification audits?
Quality certification audits are conducted by accredited certification bodies or registrars that specialize in assessing compliance with specific quality standards such as ISO 9001, AS9100, ISO 13485, etc.
NEWS & ARTICLES
The Latest News
CE marking
CE marking The CE marking is governed by European Union (EU) legislation and regulations. It indicates that a product complies with essential health and safety
רישום ספק משרד הבטחון
רישום ספק משרד הבטחון על ספק המבקש לקבל מעמד של ספק מוכר , יש לפנות למרכז לשילוב ספקים במנה”ר . הטיפול בבקשה יתבצע בתהליך הכולל
אגף ציוד רפואי
אגף ציוד רפואי אגף ציוד רפואי – אמ”ר, עוסק ברישום אמ”ר במדינת ישראל, מתן היתרי יבוא מסוגים שונים לאמ”ר, מעקב אחר שיווק אמ”ר והנפקת מסמכים
A 510(k)
FDA A 510(k) is a premarket submission made to the U.S. Food and Drug Administration (FDA) to demonstrate that a medical device is substantially equivalent
Safety and Clinical Performance
SSCP Safety and Clinical Performance Safety and Clinical Performance (SSCP) is a document required for certain medical devices under the European Medical Device Regulation (EU
MDR
MDR The Medical Device Regulation (MDR) is a comprehensive regulatory framework that governs the manufacture, marketing, and distribution of medical devices within the European Union
