Joytech has updated our ISO 13485 certification with a newly approved production base and new product categories.
This means that all new Joytech products on sale are manufactured under an ISO 13485 certified management system.
What is ISO 13485?
ISO 13485 is an internationally recognized standard for quality management systems specific to the medical device industry. It is designed to ensure that medical devices consistently meet customer and regulatory requirements. The standard covers all aspects of a medical device's life cycle, including design, development, production, storage, distribution, installation, servicing, and disposal.
Key Aspects of ISO 13485:
· Quality Management System (QMS): Establishes a robust QMS to manage processes and ensure product quality.
· Regulatory Compliance: Ensures compliance with relevant regulatory requirements.
· Risk Management: Incorporates risk management principles throughout the product lifecycle.
· Product Realization: Covers all stages from design and development to production and post-market activities.
· Process Control: Emphasizes the importance of controlling processes to maintain product quality.
· Continual Improvement: Focuses on the continual improvement of processes and systems.
Certification by ISO 13485:
When a company is certified by ISO 13485, it means that an independent certification body has audited the company’s quality management system and verified that it meets the requirements of the ISO 13485 standard. This certification indicates that the company has established effective processes and controls to ensure the safety and efficacy of its medical devices.
Implications of ISO 13485 Certification:
· Regulatory Acceptance: Helps in meeting regulatory requirements in various global markets, which is crucial for marketing medical devices.
· Customer Confidence: Enhances trust and confidence among customers and stakeholders regarding the quality and safety of the products.
· Market Access: Facilitates entry into new markets where ISO 13485 certification is a prerequisite for regulatory approval.
· Operational Efficiency: Promotes streamlined processes and continual improvement, leading to operational efficiency.
· Risk Management: Ensures that risk management practices are effectively integrated throughout the product lifecycle.
Joytech’s new facility at No. 502 Shunda Road has been in production since 2023.
Covering an area of 69,000 square meters with a total operational built-up area of over 260,000 square meters, the new facility is equipped with automated production, assembly, and packaging lines, as well as automated three-dimensional warehouses. Most of Joytech’s products currently on sale are now being produced at this new facility.
For more details, we welcome you to visit our facility!
