Abu Dhabi
Other
1-3 yrs
other
other
ISO 13485 is an internationally recognized standard that sets out the requirements for a quality management system (QMS) tailored specifically for the medical device industry. Achieving ISO 13485 certification helps organizations demonstrate their ability to design, manufacture, and deliver medical devices that consistently meet regulatory and customer requirements.
This standard focuses on risk management, product safety, and compliance throughout the entire lifecycle of a medical device, from initial concept and development to production, distribution, and post-market activities. It covers critical aspects like documentation, supplier management, and validation processes to minimize risks and ensure high-quality outcomes.
Obtaining ISO 13485 certification is essential for manufacturers looking to access global markets, as it is often a prerequisite for regulatory approvals in regions like the European Union and North America. The certification not only enhances trust among healthcare providers and patients but also supports continual improvement, ensuring devices remain safe and effective over time.
1. Only meet in public place.
2. Never pay and transfer money in advance.
3. Inspect the product before you buy.
