Makrocare
Member
MakroCare offers specialized Medical Device Quality Management System (QMS) Consulting and Standard Operating Procedure (SOP) Management services, tailored to support medical device manufacturers in achieving regulatory compliance and operational excellence. With an increasingly stringent regulatory environment and evolving industry standards, our expert team provides comprehensive guidance to navigate the complexities of QMS implementation and SOP management effectively.
Our QMS consulting services encompass a wide range of activities, including gap analysis, risk assessment, and development of customized QMS frameworks aligned with regulatory requirements such as ISO 13485 and FDA Quality System Regulation (QSR). We work closely with clients to assess their existing quality processes and identify areas for improvement, providing strategic recommendations to enhance efficiency and ensure compliance.
for more info: https://www.makrocare.com/devices/qa-qms/
Our QMS consulting services encompass a wide range of activities, including gap analysis, risk assessment, and development of customized QMS frameworks aligned with regulatory requirements such as ISO 13485 and FDA Quality System Regulation (QSR). We work closely with clients to assess their existing quality processes and identify areas for improvement, providing strategic recommendations to enhance efficiency and ensure compliance.
for more info: https://www.makrocare.com/devices/qa-qms/
