Medical devices have strict requirements for quality management that follow the international standards of ISO 13485. It’s imperative that companies in the medical device industry follow all of the guidelines to ensure that the products they are making meet all of the regulatory requirements.
What Is ISO 13485?
This International standard covers the product life cycle of medical devices starting from the development and the design of them. It also covers the installation and any servicing that may be required in the future. All companies dealing with medical devices have to maintain a quality management system to manage the following:
- Quality control
- Record-keeping
- Documentation
Along with the regulations described above, there are also other requirements that must be met for the ISO 13485 standard, which include traceability, equipment and processes validation and risk management. As well, the ISO 13485 protocols emphasize the importance of measuring and monitoring performance metrics and the need to implement continuous improvement.
ISO 13485 Document Control Software
Companies working in the medical device industry should use a software tool that has been designed to help companies comply with the standards of ISO 13485. This ISO 13485 document control software helps companies reduce their costs, maintain a competent quality management system and improve efficiency across all the various sectors of the production.
Medical Device Document Control Software Benefits
Companies using medical device document control software report improved compliance. Quality management processes can be automated easily to make sure that compliance is maintained while following all guidelines.
Documents can also be better managed and compliance can be reported by various team members along the flow of the manufacturing process. The ISO 13485 document control software can also ensure that the workers that need to receive specific information are provided with the data on time while those that don’t need to have the details of the documents are not allowed to have access to them. Only authorized personnel can be provided with authorization to access sensitive material.
Efficiency across the board has been seen by companies that are using medical device document control software. There is less time required to manage all the systems and processes can quickly be automated such as training management, action tracking and much more. ISO 13485 document control software allows employees to focus on other important tasks at hand by freeing up resources.
Industries can also expect to experience improved collaboration amongst the various members of the workforce and teams. The ISO 13485 software uses a centralized dashboard so that information can be shared and accessed by anyone that needs it. As a result, there is improved communication about any problems or issues that arise and team members can work as a collaborated group to resolve anything that may need to get sorted out.
Risk management is also improved with this software since any type of risk can be assessed and managed more effectively. Data can be analyzed and tracked and any potential risks may be mitigated before becoming larger issues.
Look for the Best ISO 13485 Software
These are just some of the many benefits a company can expect to receive by using ISO 13485 software. When you consider all of the benefits listed above you can see how they would all lead to significant cost savings. When you need the best of the best for your quality management system, examine the strength and flexibility that our medical device document control software provides.
