PMS & Vigilance
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 (AI-based) medical device, IVD or drug-device combination. 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
Download
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Contact
Contact us
Get in touch with us free of charge to discuss your individual needs and find out more details about our services.
Your direct line to us
Let's work together to strengthen your competitive advantage, broaden your horizons and enter new markets. Click below to get in touch and take the first step.
NSF Prosystem GmbH
Beim Strohhause 17
20097 Hamburg
+49 40-668-788-199
