ISO 13485:2016 Standard – Medical Devices

ISO 13485:2016 Standard – Medical Devices

Introduction The ISO 13485:2016 Standard – Medical Devices plays a crucial role for medical providers. Organizations that adopt this standard prove that they can offer medical devices and related services that satisfy regulations and the needs of purchasers. It Lays out the requirements for an effective and quality management system adapted to the medical industry. Organizations aiming […]

ISO 14971 Certification

ISO 14971 refers to the risk management in medical devices. It is developed to mitigate the risks in the medical device industry.  Obtaining ISO 14971 for the organization ensures that the medical devices are safe and effective to use. Risk management is an important aspect of the medical device lifecycle. It helps to enhance the […]

ISO 13485 Certification 

ISo 13485 sets standards for Quality Management Systems in the medical devices industry to ensure safety and compliance. ISO 13485 establishes a framework for organizations to ensure consistent product quality, safety, and regulatory compliance, emphasizing risk management and process control throughout the product lifecycle. Adhering to this standard is often crucial for entering markets in […]