Subscription program helps startups lay the foundation for FDA QSR and ISO 13485 medical device compliance
Alamo, CA – July 27, 2020 – Cannon Quality Group (CQG) today announced a new medtech quality management program designed to help startups set the foundation for a quality management system compliant to FDA QSR and ISO 13485 requirements.
Called “Device Compliance Essentials”, the program combines a comprehensive set of templates for early Standard Operating Procedures (SOPs) with live coaching sessions. The templates cover fundamental areas important to startups like document control and design control.
www.cannonqualitygroup.com/services/essentials/
“For early stage pre-seed, the point is to make sure you have legacy on your design”, said CEO Nicolle Cannon in an interview. “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, and design controls. If you’re going to purchase somebody’s ideas, you want to make sure you have those ideas in a way that’s both documented but also 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 Essentials 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 we’re ready to get into submission, I’m going to be spending more time and money, so now I want more controls,” Cannon said. “If I find we have to go back to development, I’m not going to spend money on supplier controls right now for example. Focus purely on design control and spend more time and money later.”
www.cannonqualitygroup.com/services/essentials/
The Compliance Essentials for Medtech Startups program 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.
About Us: Cannon Quality Group provides outsourced Quality Management System solutions that are efficient and compliant. Cannon’s number one priority is delivering QMS solutions that make sense for the stage and goals of its clients’ business. Cannon Quality Group’s mission is to be the Change in Quality. www.cannonqualitygroup.com
