3 Major Challenges Faced by Medical Device Companies in Software Development

Posted by Orthogonal on October 4th, 2019

Developing software for medical devices is not as easy as developing a typical software. It’s a whole different ball game. Thanks to the international regulatory requirements defined by bodies, such as International Organization for Standardization (ISO), and International Electrotechnical Commission (IEC), which make designing and development of software for medical devices time-consuming and much more complex. When developing software for a medical device, companies need to comply with these regulatory requirements to ensure the software does not pose any risks to the user(s) and that identifiable risks can be properly controlled—in the event of an accident—to minimize the potential harm. The task is challenging! Here are 3 major challenges faced by medical device companies in software development to stay compliant-

ISO13485 Compliant QMS - Implementing a compliant ISO13485 quality management system (QMS) includes the presentation of rigorous planning and execution documentation. it means assembling a Design Technical File (DTF), and giving evidence that the company operates within the QMS. In other words, companies must prove that they know what they are doing in order to demonstrate consistency in their software development, as opposed to achieving success by luck in a typical software.

Digital Document Control for Fully Electronic QMS - Both FDA and ISO13485 require a document control system that ensures product safety and reliability. In order for a medical device company to pass regulatory product approval, they must record detailed specifications, including any approved changes to the specifications. Regulatory audits require a documented historical trail, for instance, the history of all the changes that were requested, approved and implemented during the software development cycle. Document control requirements are described in ISO 13485:2016 §4.2.4 and §4.2.5, 21 CFR 820.40, and 21 CFR 11. Among all, the biggest roadblock is 21 CFR 11, which also requires the validation of the electronic document management system and electronic signatures.

A Compliant Risk Management Solution fully integrated into the Development Environment - Prior to the release of products on the market, the regulatory framework requires the assessment and mitigation of all reasonably foreseeable risks, which includes determination of key hazards, risks, mitigations, and failure modes. All the risks, mitigation actions, and verifications must be reported in a Risk Report, while the medical device risk management process is documented in a Risk Management Plan.

Considering the challenges you face in staying compliant with the regulations, it’s better to partner with an expert specializing in designing and developing software for medical devices—for a new project. It does not only allow you to build elegant companion software for connected medical devices but also helps you achieve peace of mind knowing your software is developed in compliance with the regulatory requirements.

Author’s Bio – The author is an online blogger. This article is about challenges faced by medical device companies in software development.