Company: Beyond Air Industry: MedTech Location: New York, USA MedBoard Solutions Used: Regulatory, Clinical, PMS, Market Research
Many companies are recognizing the importance of having a digital ecosystem where organization-centric knowledge can be built, and time can be saved on manual and repetitive tasks in ensuring compliance with all the requirements in the industry.
Bo Kim, Senior Director of Regulatory Affairs at Beyond Air, shared with us her experience in the adoption of MedBoard in their organization.
With over ten years of experience in quality assurance and regulatory affairs, Bo Kim joined Beyond Air, a MedTech company revolutionizing the industry with a patented technology to generate unlimited, on-demand, nitric oxide (NO) using room air.
What was the problem?
In this MedTech industry, regulatory intelligence is a crucial element in an organization’s strategy. It involves systematically collecting and analyzing the latest regulatory updates that impact an organization’s operations to ensure compliance. This task becomes even more challenging for smaller organizations that lack the resources of larger companies.
” As a regulatory professional, there are limited tools to aggregate relevant information to ensure your products remain compliant with an ever-changing market. While larger organizations may have the dedicated resource for regulatory intelligence, data analytics and project management, smaller organizations rely on a few individuals to get the same work done.
The challenge is having the assurance that you’ve gathered all relevant data for ongoing post market and regulatory assessments, analyzing its relevance and translating and implementing these changes within your organization. “
Bo Kim, Senior Director Regulatory Affairs, Beyond Air
The Solution: MedBoard
Recognizing these challenges, Bo Kim highlighted how adopting digital tools like MedBoard has transformed their approach to regulatory intelligence with an ‘all-in-one’ solution, improving their proactivity in implementing actions.
” MedBoard is unique “
“… in that it not only provides real time access to source quality data but that it incorporates documented workflows so that actions can be assigned and implemented in a timely manner. It is also able to produce reports and objective evidence to demonstrate and support the Organization’s compliance to current standards and requirements.”
Bo Kim, Senior Director Regulatory Affairs, Beyond Air
Regulatory, Clinical, Post-Market Surveillance, and Market Research. These are the areas where MedBoard is supporting Bo and BeyondAir providing accessibility to instant and trusted information and tools for managing Systematic Reviews, Tasks and Actions, and Evidence in one place, where everything is connected and ensures traceability.
What do you like best about MedBoard?
” The best aspect about MedBoard is that is easy to use and can be adopted seamlessly.
… The interface is simple and intuitive and therefore there is no learning curve to be able to utilize the application right away.”
Bo Kim, Senior Director Regulatory Affairs, Beyond Air
Our commitment is focused on making processes faster and easier, eliminating repetitive tasks, and ensuring that professionals focus on what truly matters. In this context is of paramount importance to keep the solution easy to integrate in the organization’s processes.
MedBoard in one word?
” Game-changer “
Bo Kim, Senior Director Regulatory Affairs, BeyondAir
“ MedBoard’s databases and regulatory tools make collating news, research, and intelligence easy to manage for a regulatory professional. This platform is intuitive and easy to navigate, and has been invaluable for staying up to date on all regulatory activities worldwide.“