PMS & Vigilance

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Consulting

PMS & vigilance

Does writing of mandatory reports also take overhand in your company?

Is your trend analysis based more on gut feeling than on a comprehensible methodology?

Post-market surveillance (PMS) data could provide a treasure of valuable market information, but when it comes to feeding them back into the company, information gets lost in translation?

Only a robust PMS system enables you to identify trends early on, to pragmatically address risks, and to continuously improve your product in the market.
Benefit from our experience and contact us. We are here to help.

Support

Support throughout the entire product lifecycle

The post-market surveillance system required by the MDR/IVDR describes activities that you as a manufacturer should carry out throughout the entire life cycle of your medical device or IVD. Our PMS services support you throughout the entire device lifecycle from implementing compliant process over planning of suitable PMS activities to the creation of required reports.

We help you to systematically and actively collect market experience data for your product, not only to ensure its ongoing safety and performance, but also to identify potential for improvement. You obtain this information, among other things, from your customer feedback, proactive research of publicly available information, from clinical data of post-market follow-up studies (PMCF/PMPF) or from preventive and corrective actions (CAPA).

We not only support you in updating your technical documentation with PMS data, but we also support you in optimizing your risk management, improving your device’s usability, and confirming the clinical benefit of your product.

Service

Our consulting services for you!

  • Establishment of a robust PMS system including the interfaces to quality management processes according to EU MDR/EU IVDR, EN ISO 13485 and 21 CFR Part 820 
  • Optimization of the processes for complaint handling and vigilance according to international regulatory requirements
  • Optimization of risk management according to ISO 14971, cybersecurity according to IEC 81001-5-1 and usability according to IEC 62366-1
  • Review and creation of PMS, PMCF and PMPF plans
  • Review and creation of PMS reports and periodic safety update reports (PSUR)
  • Review and creation of the summary of safety and clinical performance (SSCP, SSP)
  • Support for Field Safety Corrective Actions (FSCA)
  • Support in the evaluation of data sources
  • Establishment of methods for trend analysis

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News

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NSF Prosystem GmbH
Beim Strohhause 17
20097 Hamburg

+49 40-668-788-100

+49 40-668-788-199

info-medicaldevices@nsf.org