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Case Studies > Ready for 510(k) in 90 days

Ready for 510(k) in 90 days

Technology Category
  • Functional Applications - Computerized Maintenance Management Systems (CMMS)
  • Functional Applications - Enterprise Resource Planning Systems (ERP)
Applicable Industries
  • Healthcare & Hospitals
  • Life Sciences
Applicable Functions
  • Business Operation
  • Quality Assurance
Use Cases
  • Regulatory Compliance Monitoring
Services
  • System Integration
  • Training
The Challenge
SimBioSys faced the typical challenge faced by any life science start-up: the blank slate. The company in its fledgling state had no internal regulatory expertise or a functioning quality management system. Besides a handful of documents in a OneDrive folder, the company lacked a real quality structure or documented basics like a quality manual. When VP of Regulatory & Quality Hilary Baldwin joined the team, she brought some valuable eQMS experience with her and recognised the powerful business benefits of going straight to a digital eQMS and sidestepping paper altogether. The remote, software-focused and pro-digital culture of the business supported this decision. Hilary's first task was therefore to position the company for success by implementing a suitable, trusted eQMS platform to build the company's digitized quality system into. Along with VP of Software & IT Michael Hallock, she began the search.
About The Customer
SimBioSys is developing a Class II software as medical device (SaMD) platform to revolutionize 'computational oncology'. By digitally modelling cancer behavior, including tumor growth and medicinal impact, SimBioSys' device will unlock precise, pre-simulated cancer care that saves lives. The company is in its early stages and faced the typical challenges of a life science start-up, including a lack of internal regulatory expertise and a functioning quality management system. The company had a handful of documents in a OneDrive folder but lacked a real quality structure or documented basics like a quality manual. The remote, software-focused, and pro-digital culture of the business supported the decision to go straight to a digital eQMS and sidestep paper altogether.
The Solution
Hilary had implemented MasterControl in a previous role and hadn't enjoyed the experience. It was critical she found a system that was easy to use, could be quickly validated, and would accelerate SimBioSys' journey to market. A colleague from a previous role, Becki, had implemented Qualio at her own company Synthego and passed their first ever FDA submission with flying colors. After a glowing endorsement of Qualio and its ease of use, Hilary wanted to try the system herself. The fast, easy eQMS set-up Hilary needed was delivered by Qualio. Hilary worked with Sumatha in the Qualio+ team for targeted QA/RA support that accelerated SimBioSys' quality and compliance preparations. Sumatha used her 20 years of medical device industry expertise to help populate SimBioSys' shiny new eQMS with templated content, and to advise Hilary and the team on their 510(k) and ISO 13485 journey. As VP of Software & IT at an SaMD technology company, Michael was keen to make efficient, digital work as widespread as possible. After widespread frustration within the team caused by Excel-driven design control work, Qualio provided an integrated, built-for-purpose eQMS platform that provided 'the missing piece of the puzzle' and makes quality and compliance natural, enjoyable and automatic.
Operational Impact
  • The company's first Qualio users logged in within a month of purchase, and a complete QMS was built into the software in just 90 days.
  • Everyone in the team, from staff to contractors and consultants, now use Qualio for document access and training activities, from HR and HIPPA to privacy, day-to-day SOPs and ISO 13485 readiness.
  • Hilary's favorite Qualio feature is her ability to 'poke' colleagues with training reminders, helping her embed business-wide readiness for ISO 13485 compliance.
Quantitative Benefit
  • 20 hours of quality admin time reclaimed every single week.
  • 1 month cut from marketization prep time.
  • 110 QMS documents linked and controlled in a centralized library.

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