Life Sciences - Medical Devices

Achieve quality assurance and regulatory compliance for global markets and industry standards

Quality and Regulatory Services for Medical Devices

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

Contact us to learn more about regulatory services >

Quality assurance

  • QMS support (ISO 13485)
  • Document / records management
  • DHF remediation
  • Quality engineering
  • QMS software implementation
  • Risk management (ISO 14971)

 

Contact us to learn more about quality assurance >

Client Stories

A global healthcare company

A 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.


Read the client story >

Client Stories

Top 5 US multinational medical devices company

A 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.



Read the client story >

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.

Listen to the podcast >

Key contacts

Sourav Gupta

Global Portfolio Manager, Life Sciences

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