-
-
Call for help
-
Address
G-5A, Ground Floor, Next to Janakpuri East Metro Station, Mahavir Nagar, New delhi 110018
ISO 13485:2016
Services
ISO 13485:2016
ISO 13485:2016 is an international standard that defines the requirements for a quality management system (QMS) specific to the medical device industry. Published by the International Organization for Standardization (ISO), its purpose is to ensure that the various organizations involved in the design, development, production, installation and operation of medical devices establish and maintain good health care systems.
The standard places a strong emphasis on risk management and regulatory compliance, addressing the unique and complex challenges of the medical device industry. ISO 13485:2016 provides a framework for organizations to demonstrate their commitment to providing safe and effective medical devices that meet customer and regulatory requirements.
The key elements of the standard include creating good policies and objectives, comprehensive documentation, process control and a focus on continuous improvement. Different teams are required to conduct risk analysis and implement controls throughout the product life cycle, from design and development to manufacturing and post-marketing activities.
ISO 13485:2016 promotes the concept of process systems, encouraging organizations to identify, manage and evaluate integrated processes to improve overall performance and quality. It serves as a basis for various organizations that require compliance with the laws and authorities of the world, thus increasing market opportunities for their medical devices.
Compliance with ISO 13485:2016 is a requirement for medical device manufacturers and suppliers who want to demonstrate their commitment to quality, safety and process compliance in a competitive global market. Adherence to this standard builds customer confidence, facilitates market access and supports the success of companies operating in the medical device sector.
