One single QMS that has to be compliant to EN ISO 9001:2015, EN ISO 13485:2016, 21 CFR Part 820 QSR, MDSAP, and EU MDR QMS requirements
Gaps in QMS processes for compliance to EU MDR regulations
Lack of updates to existing QMS documents for current way of work
Indegene established a dedicated team of qualified regulatory and quality professionals with knowledge of EU MDD/MDR, ISO 13485, ISO 9001, MDSAP, and US FDA 21 CFR requirements to partner with the client for the given scope of the project.
Detailed gap assessment of the existing QMS against applicable standards and regulations with clear identification of gaps.
Remediation and all QMS documents to address the gaps and make it compliant to applicable standards and regulations.
Standardization of the QMS architecture with clear identification of procedures, work instructions, templates and forms.
Technical support in detailing and augmenting processes per requirements of applicable standards and regulations and drafting of new QMS documents
Quality, compliance, and timelines
First draft acceptance
QMS documents drafted, reviewed and delivered in 12 weeks