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Orcanos – Adaptive compliance software to support the ever changing medical device regulation

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Overview

As a startup in the medical device industry, it can be challenging to navigate the ever-changing landscape of regulations and market demands. As your company grows and evolves, your software and systems need to adapt accordingly. In this post, I want to compare a startup that needs to change and adjust to a software that is adaptive and can be configured based on changing regulations, size, and company position in the market.

Managing growth challenges

Imagine you’re a small medical device startup that has just launched your first product. Initially, you may have only a few employees, and your regulatory compliance needs are relatively simple. However, as your company grows and your product line expands, your compliance needs will become more complex. You would need to handle topics related to manufacturing, supporting product nonconformities, generating CAPA, and more. Additionally, changes in regulations, shifts in market demand, and company acquisitions may require you to adjust your systems and processes even further. A CAPA process for a 2-year 10 employee pre-market startup is not the same process as 10 years, 50-employee manufacturer with customers and products in the market.

Supporting growth with configuration

Now, imagine you have a software solution that is adaptive and can be configured to meet your changing needs. With this software, you can easily adapt users and roles to support the growth, adjust workflows and e-forms, and configure the system to meet your unique compliance requirements. Additionally, this software is designed to be highly configurable, so it can adapt to changes in regulations or market demand without requiring development efforts.

Enable growth with SaaS

As your company grows, you can easily scale the software to meet your needs. With a cloud-based solution, you don’t need to worry about purchasing and maintaining hardware or servers, the software’s intuitive user interface makes it easy for new employees to learn and use the system, reducing training time and costs.

In contrast, traditional software solutions can be inflexible and difficult to adapt to changing needs. Customizing the software can be expensive and time-consuming, and adding new processes or modules can be a significant challenge. Additionally, updates and upgrades may require extensive development efforts and can be costly.

Conclusion

In conclusion, medical device startups need software solutions that are adaptive and can be configured to meet their changing needs. With an adaptive software solution, startups can easily adjust to changes in regulations, market demand, and company position in the market. Additionally, scalable cloud-based solutions can help startups avoid expensive maintenance costs, reduce training time and costs, and provide greater flexibility for growth.

The post Orcanos – Adaptive compliance software to support the ever changing medical device regulation appeared first on Orcanos: Quality Management System: ALM Software Solution Tool.


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