The Customer
A UK-based medical devices and technology company that develops advanced radiation therapy solutions to treat cancer and dermatological conditions for patients worldwide
The Need
- 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 medical device QMS processes for compliance to EU MDR regulations
- Lack of updates to existing QMS documentations for current way of work
The Solution: A Compliant Medical Device QMS
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 EU MDR gap analysis of the existing QMS against applicable standards and regulations with clear identification of gaps.
- Remediation and all QMS documentation to address the gaps and make it compliant to applicable standards and regulations.
- Standardization of the medical device 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
Outcomes
By addressing the identified gaps in QMS processes, Indegene was able to ensure a meticulous remediation process and enable timely submissions while ensuring compliance to regulatory requirements. With the augmented process, over 155 documents were created and delivered efficiently within a 12-week timeframe.
Looking out for regulatory compliance collaboration? Contact us now to explore about our quality management system remediation capabilities.100%
Quality, compliance, and timelines
90%
First draft acceptance
155+
QMS documents drafted, reviewed and delivered in 12 weeks