Achieve quality and regulatory compliance.
Compliance:
Achieve and maintain 100% compliance
Timelines:
Meet regulatory timelines and deadlines
Product registrations:
Achieve higher success and time to market for device registration
Efficiency:
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
Contact us to learn more about EU MDR/ IVDR Compliance Services >
Regulatory services
- Regulatory intelligence
- IDE / 510(k) / PMA support
- Technical / medical writing
- RIMS application support
Quality assurance
- QMS support (ISO 13485)
- Document / records management
- DHF remediation
- Quality engineering
- QMS software implementation
- Risk management (ISO 14971)
Find out more
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.
Key contacts
Sourav Gupta
Global Portfolio Manager, Life Sciences
Harbir Sawhney
Global Portfolio Head, Life Sciences