- your medical products,
- your organizational structure,
- your company’s maturity, and
- your global strategy.
Both FDA’s Quality System regulation and ISO 13485:2016 give you this flexibility!
Strategically developing your QMS around your company’s needs and strategic priorities, aligning the development and improvement of your QMS with Quality Plans and Quality Checklists can optimize your compliance efforts while keeping patients the focus of your efforts.
MEDIcept is presenting this paper as a series of papers focusing on Right-Sizing Your QMS discussing QMS implementation, evolution and improvement, and ways to avoid falling out of compliance.