ISO 13485 is a recognized standard that outlines the requirements for a quality management system (QMS) for the design and manufacture of medical devices. Reducing the cost of ISO 13485 certification may seem challenging, but there are strategies you can employ to make the process more affordable:
-
Internal Competence: Building the skills and competence of your existing staff can be more cost-effective than outsourcing to consultants. This can be done by providing necessary training to your team, allowing them to effectively implement and manage your QMS. It will also enable them to prepare for the certification audit, reducing the risk of non-compliance that could necessitate additional audits. MSG provide in person, group or online training.
-
Gap Analysis: Before proceeding with the full ISO 13485 certification, carry out a gap analysis to understand where your organization currently stands in relation to the standard's requirements. This will help you identify areas that need to be addressed and allocate resources more effectively.