Requirements Management for Medical Devices | Complete Guide

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Requirements Management for Medical Devices | Complete Guide

As the old saying goes, “the devil is in the details.” This could not be more true when it comes to developing medical devices. In the ever-changing and highly complex medical devices industry, requirements management is critical for success. Whether you are a startup or an established player, you need to make sure that all of your product’s features and functions are mapped out and agreed upon before development begins. This white paper will take you through the basics of requirements management for Medical Devices, from planning to execution. It is important to remember that safety is always the top priority in this industry – so compliance with regulations must be taken into account at every step.

What is Requirements Management?

The medical device industry is a place where you can not afford any mistakes. All the medical equipment must be super-efficient and of the highest quality. This makes the development process for medical devices more stressful. But if everything is kept on track from the very beginning, things would become a lot easier. Hence, the first place to start with is managing your requirements. 

Now, what exactly is requirements management?

According to Ian Sommerville, “Requirements management is the process of managing changing requirements during the requirements engineering process and system development.” In other words, requirement management is collecting, analyzing, refining, and prioritizing all the products or requirements, in the development phase. 

The major purpose of requirement management is to ensure clear, concise, and error-free requirements to the engineering team so that they can make sure to detect errors in the system and potentially reduce the project cost as well as risk. 

Importance of Requirements Management

In Medical Devices, as we have already discussed, the medical device industry is a very critical one. Requirements management becomes even more important in such cases. If any mistake or error occurs in the development process of a medical device, it could result in serious consequences or even death. Hence, it is essential to have a requirements management system for developing any kind of medical equipment. 

A requirements management system will help you to keep track of all your requirements and make sure that they are up to date. It will also ensure efficient communication between different stakeholders involved in the project so that everyone is on the same page. 

The major benefits of implementing these tools include:

  • Greater effectiveness in project management and adding accuracy to the project controlling. 
  • Increasing and maintaining traceability on all levels
  • Increased efficient re-use and product-line management
  • Higher ability to create baselines
  • Improved knowledge of project scope to the stakeholders.

Challenges in the Medical Device Industry

  1. Enforcing Regulatory Compliance – Stringent laws, traceability, and safety are among the most important concerns for a medical device producer. Manufacturers confront difficulties in obtaining government support in the form of tax and financial assistance, subsidized research, and development due to country-specific compliance and regulatory criteria. Some important regulations include:
    • ISO 13485 – ISO 13485 is an internationally agreed quality management system that sets out the requirements for quality management specifically in the medical device industry.
    • ISO 14971 – ISO 14971 refers to the application of risk management to medical devices.
    • 21 CFR 820 – 21 CFR 820 ensures that all medical devices are safe and appropriate quality processes are used throughout development. 
    • MDR – To meet the requirements of the EU Medical Device Regulation, the manufacturers must have a broad risk-based QMS in place.
    • AAMI TIR45 – AAMI TIR45 covers the guidelines for Agile practices for the medical device development by Software as a Medical Device (SaMD). 
  1. Customer Satisfaction – To minimize product recalls and consumer dissatisfaction, product quality is critical. The medical device manufacturing sector, which is regulated by the FDA, keeps a thorough log of all data to keep up with changing legislation. Businesses may use best-in-class software to track devices by batch number, lot number, or serial number to standardize operations and reduce product recalls.
  1. Ineffective Business Processes – Managing all of a company’s products, operations, and resources is difficult. A medical device manufacturing firm must have cutting-edge technology that can be used to automate cross-functional processes, share data securely, and access files and papers from anywhere using mobile devices. By employing software that breaks down silos and supports activities such as warehouse management, production, purchasing, quality control, shipping, and other fundamental tasks, organizations will make better decisions faster.

How to Implement Requirements Management in Medical Device Industry?

The integrated, automated lifecycle management tools that have become available in recent years have helped to establish the process of requirements engineering. This process provides a structure for defining, managing, and testing requirements.

This umbrella term encapsulates various steps and processes, some of which are:

  • Requirements Gathering/Elicitation – Defining requirements refers to the process of identifying what is needed, researching and analyzing the issue, specifying what would solve the problem, and verifying that the solution meets the original need.
  • Requirements Specification/Documentation – Jotting down the system and user requirements in a clear, concise, and comprehensive manner in the form of a document.
  • Requirements Management – Requirements management involves the planning, development, verification, validation, and change management of your needs.

The goal of this process is to ensure that everyone is on the same page and that requirements are met, prioritized, and tracked.

Requirements engineering for medical devices goes hand-in-hand with the previously mentioned point but also takes into account compliance needs and traceability. In other words, you’re establishing a way to not only define your requirements while taking compliance into consideration but also to track and follow those requirements as they progress throughout development.

Automated tools are key to managing the risk traceability involved in medical device production processes and maintaining compliance with safety regulations.

Why not follow the traditional Requirements Management methods?

There are a few reasons for not following traditional requirements management methods. The first reason is that these methods are not suitable for the medical devices industry as they do not take into account the specific needs of this sector. Secondly, traditional RM methods tend to be very complex and time-consuming, which can lead to errors and delays in the development process. Finally, many of these methods require manual processes, which can be error-prone and difficult to scale.

There is a single set of criteria for a medical device that must be satisfied by both the hardware and software teams in traditional methods. In these antiquated systems, the hardware and software teams work independently, using their own separate systems, tools, and metrics to produce their work and assess their individual performance.

When these two teams return after their designated period, they’ll often find a plethora of compatibility and optimization concerns to address before proceeding. Although the hardware and software may appear to fulfill the criteria separately, they cannot be combined in order to achieve them.

This then leads to a long, troublesome process of fixing issues between the hardware and software teams. Of course, this wastes time that could be better spent bringing the overall device closer to being completed with its requirements.

What should you look for in a Requirements Management tool?

When looking for a requirements management tool, there are a few key features that you should keep in mind:

  • Traceability: Maintaining end-to-end traceability is a crucial objective to fulfill for various audit purposes and prove that all the requirements have been properly met especially in the medical device industry. In addition, it also helps in keeping track of any changes or bugs within the process. The ability to trace requirements from their inception to final delivery is critical in the medical device industry. This traceability must be maintained throughout the product’s lifecycle.
  • Compliance: There are various important standards that must be satisfied when working in the medical device industry. Every standard is for different aspects. These standards include:
    • IEC 62304 – This is an international standard that specifies life cycle requirements for the development of medical software and software within medical devices, helping medical device manufacturers meet all regulatory requirements and release products that won’t put patients at risk.
    • FDA 21 CFR Part 820 and Part 11 – This standard is for electronic documentation and electronic signatures. It outlines the administration of electronic records in a medical device company’s quality management system.
    • ISO 14971 – This is a standard that outlines the framework of risk analysis, evaluation, control, and review. It also explains a process for reviewing and monitoring the product during production and after production as well. 
  • Risk Management:  Managing risk is essential in the medical devices industry. Choose a tool that can help you to identify, assess, and mitigate risks throughout the product development process.
  • Change Management: Change is as certain as death and taxes. But this change can have various positive as well as negative repercussions. For a sensitive industry such as medical devices, managing these changes is highly essential to eliminate any sort of risk produced by changes. Thus, this is another must-have feature.
  • Report Management: Visual aids are one of the most essential requirements of any standards or regulations of the medical device industry as stated in point 1. Thus, it is important to manage them properly and keep them centralized for everyone to access encouraging a collaborative work environment. 
  • Collaboration:  Choose a tool that allows for collaboration between the hardware and software teams. This will help to avoid compatibility issues and optimize the development process.
  • Scalability: As your business grows, you will need a tool that can scale with you. Look for a tool that is flexible and can be customized to meet your specific needs.
  • Automation: Automating manual processes will help to improve efficiency and accuracy in the requirements management process.

The medical devices industry is highly regulated, making requirements management an essential part of the development process. By choosing the right tools and following best practices, you can ensure that your products are safe, compliant, and of the highest quality.

Tips for Effective Requirements Management in Medical Device Development

There are a few tips that you can follow to ensure effective requirements management in your medical device development:

  • Establish a clear process for requirements gathering and management, and make sure that all team members are aware of and trained in this process.
  • Use requirement management software to automate manual processes and improve efficiency.
  • Ensure traceability throughout the product lifecycle by tracking requirements from inception to delivery.
  • Comply with industry regulations by choosing a tool that meets all the necessary compliance standards.
  • Scale your requirements management process as your business grows by choosing a flexible, customizable tool.

By following these tips, you can ensure that your medical device development process is efficient, compliant, and of the highest quality.

Visure Requirements ALM Platform for Requirements Management for Medical Devices

Visure is a highly trusted requirements management tool in the medical device industry. The company integrates through the whole ALM processes including risk management, issue and defect tracking, traceability management, change management, and various other areas like quality analysis, requirements versioning, and powerful reporting. Some top Visure clients include Glaxo Smith Kline (GSK), Solta Medical, Health Net, and many more.

Visure’s Features:

  • Standards – Visure ensures streamlining the requirements keeping in mind to maintain compliance with various standards like IEC 62304, FDA 21 CFR Part 820, and Part 11, ISO 14971 in a cost-effective manner. Visure furthermore, supporr\ts various Agile practices as well under AAMI TIR45. These standards are dynamically traced throughout all the stages of development. 
  • Traceability – Visure also helps you in maintaining full traceability between your system and all the software requirements risks, tests, and other artifacts. Furthermore, Visure assists you in generating full traceability reports as well.
  • Risk Management – Visure connects risk, testing, and requirements in a single platform. Transform how you capture, analyze, evaluate and mitigate risks at each stage of the development process. You can easily import and list risk factors into the platform, implement the FMEA process and begin calculating risk. Once the high-risk factors have been identified, you can easily create Safety Requirements related to them.
  • Multi-tier Collaboration – Visure supports XML-based standards, like ReqIF and XRI, that help you in exchanging requirements between various different customers and suppliers. 
  • Security – Visure ensures proper security of information and requirements. The tool does this through its rigorous access policy where only certain people can access the artifacts even at the elementary level. 
  • Quality Analysis – Visure’s Quality Analyzer allows you to perform semantic analysis of the requirements to identify the quality of the requirements. Therefore, if the requirement is low quality, the tool will automatically flag them with ambiguity or inconsistencies.

Conclusion:

Requirements management is a process for documenting, organizing, reviewing, and managing the requirements of a project. The purpose of requirements management is to ensure that all stakeholders are aligned on what needs to be built and that the end product meets the needs of the customer. When it comes to developing medical devices, adherence to rigorous requirements management processes is essential for success. Visure Requirements ALM Platform can help you implement an effective requirements management strategy for your medical device development projects. Request a free 30-day trial today to see how our platform can help you streamline your workflow and improve communication among stakeholders.

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