Best Practices for Developing Medical Device Software

Until recently, only a few large and well-established hardware-manufacturing organizations were formed in the Medical Device industry. As those devices have now become more software-driven, so the software development companies have also started to work in close association with the manufacturers of medical devices. These software companies now are also independently developing medical products built for consumer devices, e.g. iPhone or Android apps, in addition to supplying software to those product producers.

Consumer electronics' pervasiveness makes it easy for almost any software company or app developer to enter that highly controlled market. Today most software for medical devices in the EU is developed by small and medium-sized software organizations. But, whatever their software development expertise, most of them are new to the medical device systems world.

Medical device software development team can take these 3 way approach and consider them as some of the best practices for medical device software development. 

• Implement a Quality Management System (QMS)

• Add Digital Content Control to the QMS 

• Automate the risk management process

Develop and implement an ISO13485 and IEC62304 compliant Quality Management System

Companies must demonstrate that they operate according to applicable standards and regulations when delivering software to medical device manufacturers. Clients (hardware manufacturers) want to make sure that the product is developed that also meets a standard that they feel comfortable for regulatory agencies to submit and defend. A software developer must implement a Quality Management System and document their activities to achieve this. Irrespective of whether the software is developed under the Quality Management System of the customer or supplier, developers must be thoroughly acquainted with applicable standards and regulations, and documentation management in general.

Add Digital Document Control to the Quality Management System

The next move is to incorporate digital document management, with a compliant Quality System and all medical device related documents on confluence. Setting the document access permissions is essential to compliance goal, as the hard deletion of documents has to be extensively limited and document decommissioning has to be managed as part of the process and document workflow. In addition to those safeguards, audit trails must be connected with documentation from the Quality System to keep track of the preserved documents as long as necessary.

Automate the Risk Management Process

Some small teams of software for medical devices use Excel to manage QMS, but it soon becomes apparent that managing large development projects with spreadsheets becomes impossible; the potential for human errors makes audits a process of nerve-racking. Safety-critical systems are increasingly filled with software, and software developers are mostly comfortable to work with transparent and integrated solutions where there is a seamless connection between different features of system development. The important advantage of integrated approaches is the use of existing systems within the organisation. The use of existing systems would pace up the automation process, and plan for regulatory audits. In addition, risks need to be handled in a central system for distributed projects, which can allow all stakeholders to contribute to risk identification, assessment, and mitigation. Teams need an affordable solution that saves money for the firm by preventing investment in a brand new set of devices. 

When medical devices become more software-dependent, and in some cases which are completely hardware-free, incorporation of regulatory compliance into the software development process is not only necessary, but mandatory.