The medical device industry is a highly regulated environment that requires a stringent adherence to quality. So, you need a QMS software that helps you manage the project process to enhance team collaboration, reduce time to market, and manage critical information that can be immediately accessed.
But with so many QMS software options in the global market, how do you choose the one that’s best for your specific medical device needs? Here’s a helpful checklist to consider.
✓ Research regulatory requirements that apply to your medical device.
Ensure that you have a strong grasp of the regulations and certifications applicable to your device and country. Your QMS software features and quality processes should be designed around these regulations to ensure a culture of compliance in safety across your organization.
✓ Your QMS software needs to be priced for purpose.
Use a checklist to determine the key purposes the QMS will serve and who will use it. This will help you decide if the QMS software needs to be feature-packed and modern or relatively inexpensive.
✓ Know the software’s limitations.
QMS software contributes to increased quality and cost savings, but it does have its shortcomings. Be sure the software must be easy to implement and customize when needed. It should also be user-friendly and require less maintenance and upgrades while being stable and secure.
✓ Figure out the resources.
Read reviews of the ISO 13485 Quality Management System or ask for case studies to understand its timing and resources. The software must be capable of identifying common trends in complaints and failures on the production line. It should be able to streamline quality across all the key functions while maintaining compliance. It should facilitate effective resource utilization.
✓ Choose a trusted partner with expertise.
There are myriad companies worldwide offering QMS solutions ranging from cheap to expensive. Choose to reputable partner that is trusted in the industry. They must have proven experience in implementing and supporting QMS software for industries similar to yours, with a firm understanding of the standard regulatory and safety procedures. Their software will be pre-built with many compliance procedures that are common to your requirements.
Software for the medical device manufacturing industry is constantly advancing, so the ISO 13485 Quality Management System you choose must be designed for scalability and integration for the long run. If you’d like to learn more about Medical Device Quality Management System that works to support the regulated environment your business supports, we can help.