Why is ISO 13485-certification required?
ISO 13485 is recognized globally as the benchmark for quality management systems in the medical device industry. Achieving this certification ensures compliance with various international regulations, facilitating market access in regions such as the European Union, Japan, the United States, and more.
Regulatory bodies often mandate ISO 13485 certification for market entry and product approval, as the standard demonstrates the ability to consistently meet customer and regulatory requirements. This certification not only ensures that products are safe and effective but also that manufacturing processes are reliable and consistent.
In a highly competitive market, ISO 13485 certification also differentiates manufacturers from their competitors. It serves as a mark of quality and reliability, which can be a decisive factor for customers and business partners when selecting suppliers. The certification signals a commitment to maintaining high standards, reducing risks, and continuously improving processes. Additionally, it fosters customer trust and confidence, which are crucial for establishing long-term business relationships. By adhering to ISO 13485, manufacturers can streamline their operations, improve product quality, and enhance overall efficiency, ultimately leading to increased market share and profitability. In essence, ISO 13485 certification is not just a regulatory requirement but a strategic advantage in the medical device industry.
In addition to the procedures and templates required for ISO 13485 compliance, LEXQARA also develops the necessary documentation to meet applicable regulatory requirements, such as those outlined in the (EU) 2017/745 regulation.
