Steps for Getting CE Marking

Configuration management for medical device is a system engineering process for establishing consistency of a product’s attributes throughout its life. Configuration management for medical device is a system engineering process for establishing and maintaining consistency of a product’s performance, functional and physical attributes with its requirements, design, and operational information throughout its lifecycle. The configuration management process facilitates orderly management of product information and changes for purposes as to revise capability, improve performance, reliability, or maintainability, extend life, reduce cost, reduce risk and liability or correct defects. Configuration Management for medical device must include – ·          Enterprise or Unified Supply Chain Configuration Solution ·          Error-Proofing ·          Intuitive and Flexible ...

  Post-saleof medical devices , it is critical to monitor how efficiently the device is working, its downtime, any faulty findings, any risk it poses to the users, end-users etc. In short, continuous monitoring of the medical device must be conducted to check its safety and performance. Any statistically significant increase in serious incidents (severity of risks) as per the trending report leads to appropriate control measures taken like the Corrective and Preventive Actions (CAPA) or the Field Safety Corrective Actions (FSCA) for any Field Safety Notice (FSN) generated. PMS activities must be performed as per Article 83 to Article 89 including data gathering, PMS Plan, PMS/PSUR report, vigilance reporting, trend reporting, FSN and FSCA. Post-Market Surveillance (PMS) & PSUR PMS under EUMDR   Stringent implementation & monitored by PRRC Included in the technical documentation Report to Notified Bodies & Competent Authorities The PMS system will co...

  Risk is common word in human definition and even child learns the word risk from very age when he starts learning and start doing some adventure of childhood Everybody knows the word risk as common word vocabulary it has lot of importance in medical device field. Though various documents are available, and experts have devised various methods to assess the same. Though we learnt risk based on our perception like we consider certain act as very risky and scared to do the same, stunt man who has practiced that act, does it so easily and risk in his or her perception for that act is very low. This type of perception cannot work in regulated world where we define risk based on assessment as defined in various well accepted standard documents. Let us understand this Medical devices, those have helped improv the standard of life for thousands and thousands of individuals. All those are associated with some sort of risk but are still released based on assessed risk. That risk is...

Process Validation is conducted to ensure consistent delivery of quality products meeting its predetermined specifications/requirements and quality characteristics. This enables to ensure the complete safety & efficacy of medical device. IQ, OQ, PQ protocols are methods for demonstrating that equipment being used or installed will offer a high degree of quality assurance such that production processes will consistently manufacture products that meet quality requirements. Installation Qualification (IQ) Newly installed or modified equipment must first be validated to determine if it’s capable of producing the desired results through Design Qualification (DQ)—a protocol defined as the documented verification of a proposed design’s ability to meet the requirements it needs to fulfill. Operational Qualification (OQ) Operational qualification (OQ) is performed after meeting each protocol of IQ. OQ’s purpose is to determine that equipment performance is consistent with the us...