Managing Change Control in ISO 13485
Change control is a vital aspect of quality management for medical device companies. ISO 13485, the international standard for medical device quality management systems, places emphasis on change management. The process of change control in ISO 13485 ensures that modifications to products, processes, or documentation are implemented in a controlled manner. This helps maintain product […]
How to Get ISO 13485 Certification: A Step-by-Step Guide
In medical device manufacturing, getting ISO 13485 certification ensures quality and regulatory compliance. This international standard sets the bar for quality management systems in the medical device industry. Companies seeking to enhance their processes, meet regulatory requirements, and gain a competitive edge often ask how to get ISO 13485 certification. It requires careful preparation and […]
ISO 13485 and Regulatory Requirements: Complete Compliance
ISO 13485 is an international standard for quality management systems in the medical device industry. This is essential for medical device companies aiming to ensure their products consistently meet regulatory and customer requirements. So, let’s explore the connection between ISO 13485 and regulatory requirements. Walking down this path can help ensure regulatory compliance of your […]
