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 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 – אמ”ר, עוסק ברישום אמ”ר במדינת ישראל, מתן היתרי יבוא מסוגים שונים לאמ”ר, מעקב אחר שיווק אמ”ר והנפקת מסמכים

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

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 The Medical Device Regulation (MDR) is a comprehensive regulatory framework that governs the manufacture, marketing, and distribution of medical devices within the European Union

IVDR The In Vitro Diagnostic Medical Devices Regulation (IVDR) is a regulatory framework established by the European Union (EU) to govern the manufacture, marketing, and

A Comprehensive Guide to Medical Device A Comprehensive Guide to Medical Device Classification According to Medical Standards Introduction:Medical devices play a crucial role in modern

AS 9100 AS 9100 is a set of aerospace industry-specific standards that builds upon the ISO 9001 Quality Management System (QMS) requirements. Developed by the

A Quality Agreement for Medical Devices A Quality Agreement for Medical Devices is a formal document that outlines the quality-related responsibilities and expectations between parties

Designing and developing medical devices Designing and developing medical devices in accordance with ISO 13485, an internationally recognized quality management standard for medical devices, offers

ISO 13485 is an internationally recognized standard that specifies requirements for a Quality Management System (QMS) for medical device manufacturers and suppliers. It provides a

Implementing a Quality Management System Implementing a Quality Management System: Key Steps and Benefits In today’s competitive business landscape, maintaining high standards of quality is

ISO 9001 is an internationally recognized standard for Quality Management Systems (QMS). It outlines requirements for organizations to establish, implement, maintain, and continually improve an

Benefits for a quality-certified company Enhanced Customer Satisfaction: Quality certification demonstrates your commitment to delivering high-quality products or services, which can result in increased customer