FOR IMMEDIATE RELEASE
Subscription program helps startups lay the foundation for FDA QSR and ISO 13485 medical device compliance
Alamo, CA – September 28, 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 (QMS) compliant to FDA QSR and ISO 13485 requirements.
Device Compliance Essentials for Startups
Device Compliance Essentials for Startups 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, design control and supplier quality to ensure optimal supplier audits, and are available immediately (www.cannonqualitygroup.com/services/essentials/).
The budget-friendly program consists of 9 fundamental SOP templates matched with regular coaching for startup medical device manufacturers over six months. The templates help medtech startups ensure medical device compliance and include:
- Doc Control
- Design & Development
- Software Development
- Risk Management
- Supplier Quality
- Material Controls
- NonComforming Materials
This allows a founder’s team to bring on new procedures gradually, correctly, and in a compliant fashion for only $500/month.
If the situation calls for setting up a QMS faster, or with more coaching support, CQG offers upgraded packages consisting of the 9 templates plus weekly half-hour coaching.
“For early stage pre-seed, the point is to make sure you have legacy on your design,” said CEO Nicolle Cannon. Investors are savvy at spotting too much or too little quality management in startups in which they’re considering a stake. “If you’re going to buy somebody’s ideas, make sure you have them in a way that’s both documented and proven out at some level and in a record. That’s the value.”
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.
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