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Post Market Surveillance(PMS) for Medical Device

To comply with the European Union (EU) Medical Device Regulation and US Food and Drug Administration manufacturers must conduct Post Market Surveillance (PMS) as outlined in MDR & USFDA.
The above regulators insist for Post Market Surveillance to makes every effort to assure that risks associated with medical devices have been minimized when those devices first enter the market. However, once medical devices are widely used by health care providers and patients, new issues occasionally arise.
Postmarket surveillance is a collection of processes and activities MDD & US FDA uses to monitor the safety and effectiveness of medical devices once they are on the market. These activities are designed to generate information to quickly identify poorly performing devices and other safety problems, accurately characterize real-world device performance and clinical outcomes, and facilitate the development of new devices, or new uses for existing devices.

Post Market Surveillance as per new Medical Device Regulation(MDR)

The manufacturer maintains an up-to-date systematic procedure to review experience gained from devices in the post-production phase, which include provisions referred to in Annex X (93/42/EEC), or Annex VII (90/385/EEC) and implement appropriate necessary corrective action as per harmonized standards EN ISO 13485 and EN ISO 14971:2012.

ISO 13485 gives an outline of a quality management system (QMS) structure which compels the need for a feedback system specifically to provide early warning of quality problems and for input into corrective and preventive action processes. In addition to the pre-market assessment of risks associated with a new device. EN ISO 14971:2012 specifies requirements for production and post-production information to be considered as part of the overall risk assessment process throughout the life of the device.
The need for PMS arises immediately upon commercialization of the device.

The source of Post market surveillance is divided into 2 categories

  • (a) Proactive (b) Reactive

PROACTIVE

  • expert users groups (“focus groups“)
  • post CE Mark clinical trials
  • and post market clinical follow-up studies

REACTIVE

  • complaint monitoring,
  • User feedback or from sales representatives,
  • reports from regulatory authorities,
  • In-house stability studies of sold devices
  • literature reviews,
  • service/repair information
  • user reactions during training programs
  • other bodies (e.g. the CA)
  • the media
  • warranty claims

We have developed complete solutions for regulatory compliance. Readers  contact at enquiry@i3cglobal.com for requirements in (a) Ready to use procedures (b) ready to use templets or (c) consulting requirements.

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