Transform materiovigilance and enhance patient outcomes.
Multi-country, multi-lingual support for contact centers
Meet regulatory reporting timelines and requirements
Reduced operational cost without compromising on quality
Increased operational efficiency, and continuous improvement
Transform materiovigilance and enhance patient outcomes
Post market surveillance (PMS) plays an important role in driving the product quality, performance and safety of a medical device. The regulations for PMS and vigilance reporting are highly evolving and there is a greater need to enhance patient outcomes while implementing an effective PMS system.
Atos is a digital transformation leader and brings in deep domain expertise in PMS / materiovigilance. We have a successful track record in helping companies with process optimization / transition, digital implementation, PMS and vigilance operations, complaints handling and regulatory compliance.
Complaints handling operations:
- Case intake and review
- Complaints processing
- Regulatory evaluation
- Regulatory reporting
- Contact center solutions
- AI / RPA / digital solutions
Medical device vigilance:
- PMS plan and report (PMS/ PSUR)
- Post market clinical follow-up (PMCF) plan/report
- Field safety corrective actions & notice (FSCA/FSN)
- Clinical evaluation plan and report (CEP/CER)
- e-Medical device reporting (eMDR)
- Manufacturer incident report (MIR)
- AI, analytics & RPA solutions
EU MDR post market surveillance supportA 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 >
US-based global healthcare companyA US based global healthcare company has acquired a business division of a top medical device company and partnered with Atos to help them with transitioning to a new complaints management system and provide business operations support, delivering 42% cost savings and a 30% increase in productivity.
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