The medical device sector must meet stringent regulatory requirements plus convince potential customers that they make reliable, safe products. Having a strong commitment to quality can help customers ...

Quality management system standards are a great tool for organizations wanting to plan an effective and efficient quality management system. ISO 13485, the ISO standard for medical device quality ...

This Process Capability Analysis webinar on ISO 13485 will help you understand the concepts of Process Capability Analysis (PCA) and shows how to apply it to various clauses of an ISO 13485.

YOKNEAM ILLIT, Israel--(BUSINESS WIRE)--ForSight Robotics, the pioneer in ophthalmic robotic surgery, announced today its achievement of ISO 13485:2016 certification, an international benchmark for ...

South African Health Products Regulatory Agency (Sahpra) has indicated that ISO 13485 certification is a prerequisite for the application or renewal of a medical-device license, with effect from 1 ...