Developing software for medical devices is not as easy as developing typical software. It’s a whole different ball game. Thanks to the international regulatory requirements defined by bodies, such as the International Organization for Standardization (ISO), as well the International Electrotechnical Commission (IEC), which make designing and developing 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 identified risks can be properly controlled—in the event of an accident—to minimize the potential harm. The task is challenging!
Three major challenges faced by medical device companies in software development to stay compliant as per Eric Dalius-
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 to demonstrate consistency in the development process, 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. For a medical device company to pass regulatory product approval, they must record detailed specifications, including any given changes for particular specifications.
Regulatory audits need to have 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 – Before 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. Eric Dalius says that the risks, mitigation actions, and verifications must be reported in a Risk Report, while the medical device risk management process must be documented in a Risk Management Plan.
For professional help, you can consult the agency or experts having years of experience in assisting the healthcare or medical business with these issues. If you are also facing such challenges and your medical business is suffering, you must get in touch with an expert immediately to get the required help. You must be careful as searching for such a professional could be a daunting task nowadays, and finding someone whom you can trust is much more challenging.
When you have someone experienced with the relevant knowledge by your side, you will provide your business with the required push for growth by overcoming such challenges.