Achieve quality and regulatory compliance.
Achieve and maintain 100% compliance
Meet regulatory timelines and deadlines
Achieve higher success and time to market for device registration
Increased operational efficiency and cost savings
Total compliance partner for global and local quality and regulatory needs
Regulatory requirements are highly evolving and constantly changing whether it is FDA CDRH, EU MDR or UK MHRA (Post-Brexit), there is always pressure on product compliance to the market regulations.
Atos helps device manufacturers achieve quality regulatory compliance with smooth transitioning and great efficiencies. We bring in qualified QA, regulatory consultants and business domain experts to perform gap/ impact assessments and drive change management throughout the product lifecycle. We have been successfully delivering some of the large FDA and EU MDR compliance programs within stringent timelines.
EU MDR/ IVDR compliance services
- Consulting and gap assessment
- Technical file remediation, STED Clinical evaluation support
- PMS/ PSUR/ PMCF support
- Labeling change management
- UDI implementation and support
- Packaging updates
- Risk remediation
- QMS support (ISO 13485)
- Document / records management
- DHF remediation
- Quality engineering
- QMS software implementation
- Risk management (ISO 14971)
A global healthcare companyA global healthcare company with specialities in eye care, aesthetics, surgical and pharma devices partnered with Atos to help them achieve EU MDR compliance in the Post Market Surveillance (PMS) area which covered creation of the PMS plan, PMS reports and PSURs for ~150 product families. This achieved quality and compliance with 30% cost savings.
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Top 5 US multinational medical devices companyA Top 5 US multinational medical devices company partnered with Atos to support them with labeling change management for EU MDR compliance. The scope of the work included gap assessment and changes to product labels, IFUs and labeling components for multiple franchises.
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Maintaining and sustaining EU MDR/IVDR compliance for Medical Devices
Global Medical Devices and In-Vitro Diagnostic companies are all gearing up for the new EU MDR/IVDR regime. Learn how Atos has helped large organizations meet these new regulatory requirements as part of EU MDR/ IVDR compliance programs.
Global Portfolio Manager, Life Sciences