By Cannon Quality Group
Cannon Quality Group (CQG) is pleased to announce a new medtech quality management program in cooperation with Propel designed to help startups set the foundation for a Quality Management System compliant to FDA QSR and ISO 13485 requirements.
Device Compliance Essentials for Startups is a six month program combining a comprehensive set of templates for early Standard Operating Procedures (SOPs) with live coaching sessions. The templates cover nine fundamental areas important to startups, e.g., document control and design control, matched with regular coaching for a six month period.
Templates
- Doc Control
- Software Development
- Supplier Quality
- Training
- Risk Management
- Material Controls
- Design & Development
- Purchasing
- Non-Conforming Materials
Normally priced $3,000, Cannon Quality Group is offering Device Compliance Essentials for Startups free of charge to new Propel customers who sign up by March 31, 2021. The offer is only available to medical device manufacturers that are early stage (pre-FDB in California) with a design concept ready to move toward feasibility testing and that do not have a Quality Management System process in place yet.
“Quality is just good scientific process, especially as relates to design controls. If you’re going to purchase somebody’s ideas, you want to make sure you have those ideas organized in a way that’s documented, proven out at some level and in a record. That’s the value.”
If the situation calls for deploying a QMS faster or more coaching support, Cannon Quality Group offers an upgraded package consisting of the 9 templates plus weekly half-hour coaching. Alternatively, more experienced teams can elect to purchase the templates without the personal support.
“For early stage pre-seed medtech, the point is to make sure you have legacy on your design,” said Cannon Quality Group CEO Nicolle Cannon. “You have this brilliant person, the founder, usually with an idea and concept you want to get to market, and there’s a lot of activity.” Cannon said investors are savvy at spotting too much or too little quality management in startups in which they’re considering a stake. “Quality is just good scientific process, especially as relates to design controls. If you’re going to purchase somebody’s ideas, you want to make sure you have those ideas organized in a way that’s documented, proven out at some level and in a record. That’s the value.”
Medtech startups can potentially push out that first hire in Quality Management by deploying the Device Compliance Essentials for Startups program. Participants can elect for once-a-month conference calls, individual coaching, or no support at all, depending on their pace, time available, and resident skill sets.
Startups can adopt the SOPs gradually as it makes sense for their business situation. “If you’re a startup ready to get a medical device into submission, you’re going to be spending more time and money, so you’ll want more controls,” Cannon said. “If you have to return to development, you’re not going to spend money on supplier controls right now, for example. You’ll want to focus purely on design control and spend more time and money on supplier controls later.”
Device Compliance Essentials for Startups is the latest innovation from Cannon Quality Group. CQG had previously announced its Shared Supplier Audit program, which groups multiple customers of a supplier into one convenient and cost-effective audit day, as well as the Founders Club in Redwood City, offering medtech entrepreneurs a shared workplace (including a Class 7 Controlled Environment Room) in the heart of Silicon Valley to tinker for a day, a week, or months.
Cannon Quality Group has nurtured many medical device startups in its 10-year history through implementation of Quality Management Systems, and supporting clients through milestones such as California FDB certification and ISO 13485 certification. Learn more: https://www.cannonqualitygroup.com/services/essentials/
