From compliance to downtime: How Amazon Web Services is transforming the medical device industry - Verdict Medical Devices
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From compliance to downtime: How Amazon Web Services is transforming the medical device industry

20 Sep 2021

Sponsored by Kallik Sponsored by Visit Company
From compliance to downtime: How Amazon Web Services is transforming the medical device industry

Label management can be a heavy burden for medical device manufacturers, and inefficiently managed data risks failing to meet compliance standards or slowing down a device’s journey to market due to human error.

Kallik’s labelling and artwork management software, Veraciti, utilises automation, allows users to dynamically make changes or reuse assets, and gives users the tools they need to stay on top of compliance regulations.

Business is increasingly being conducted on the cloud and Veraciti is no different, but as with any software, the system is only as good as the platform it is hosted on. From security to reliable servers, customers demand the best for their data.

Amazon Web Services (AWS) offers security and server availability that users can depend on, but it’s more than a standard hosting platform. AWS takes the burden of compliance off manufacturers by monitoring the market and adapting to new requirements and standards, all while reducing the risk of downtime for round-the-clock manufacturers.

Medical Device Technology spoke with Robert Woodall, chief technology officer at Kallik, about the benefits of hosting Veraciti on Amazon Web Services.

Security and compliance

“The key to this is that best practices of security and compliance are built in,” Woodall explains. “Our architecture is based on the AWS guidelines, which means that you use all the standards for the management of the servers and management of the data they have access to.”

Amazon Web Services operates a “Shared Responsibility Model”, which relieves the customer’s operational burden.  While the customer is responsible for the guest operating system (such as updates and security patches), other associated application software, and the configuration of the firewall, AWS manages the components from the host operating system. This includes hardware, software, networking, and the physical security of the facilities in which the service operates.

“There are a lot of security services built into the platform, such as protecting customers from denial of service. A lot of companies now offer services on top of AWS because you have these options. It’s the type of technology that we need at the moment; better threat protection and ways to ensure that our customers’ data is safe.”

AWS is fully compliant with regulations such as ISO/IEC standards and GxP requirements, as well as data privacy such as HIPPA in the US and GDPR in Europe. The system streamlines compliance with automated, continuous monitoring of the market to adapt to new changes, with on-demand reporting that proves far more efficient than periodical, manual compliance checks.

Scalability and reliable servers

“We can tune AWS,” Woodall explains. “It’s easy to provide more servers and dynamically flex the capacity based on the needs of our customers. A good example of this is at the start of the year, some of our customers were running EU MDR projects.”

MDR certification of a medical device confirms that it meets all regulatory requirements for European Union medical devices, and involves the implementation of a Quality Management System (QMS). This can involve a lot of work and accumulates a lot of data.

“Because of the sheer volume of data being pushed through our system, we are easily able to scale our architecture to meet the needs of our customers based on their own operational demands. This is much easier to do through AWS than a private cloud provider.”

“Customers also benefit from availability zones,” Woodall adds. “By default, if you install a database into AWS and configure it to high availability, if there are any issues at the nearest data centre, it will automatically switch over to another at no inconvenience to the customer. They won’t even notice, and there is no risk of downtime.”

“Data centres are geographically separated, so if there is a disaster event it is unlikely that both data centres will be affected. We have seen this happen, where there has been some kind of networking issue and the system automatically moves over to the other data centre.”

Utilising AI and market monitoring

“The AWS platform has a host of built-in services that you can utilise, from monitoring systems to value-added features such as artificial intelligence (AI) and cost analysis that allows you to optimise your costs, such as finding the different types of file storage that we can use it make it cheaper to run our infrastructure.”

“We’re currently engaged in projects to unlock some AI technology for data migration so we can move our customers’ data quicker into AWS without having to use manual processes and use more automated processes through machine learning.”

To find out more about how Kallik can benefit your label management processes, download the whitepaper below.

Free Whitepaper

Six key steps medical device manufacturers must take to successfully navigate the digital maturity curve

With legislation, regulation, branding changes and the normal rigours of product design, development and testing, medical device manufacturers face constant and mounting pressure on their bottom line and their operational efficiency. In Europe alone, there are three major upcoming regulatory changes this year.

The only way companies will weather this storm and stay ahead of the competition is by embracing the benefits of digital transformation – including label and artwork management – so critical to end user safety and regulatory compliance.

Label and artwork management firm Kallik has gathered the lessons learned from the pandemic and beyond to give medical device creators to embracing digital changes and ultimately making life – and the bottom line – more safe and secure.

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