Medical Device - Reliability and Risk Assessment

Medical Device - Reliability and Risk Assessment

In the medical industry, it is a challenge to develop a Safe, Reliable product at the same time ensuring the effective end application meets all its requirements. These three aspects are not just requirements that are necessary to meet and satisfy the regulatory agencies like the FDA (Federal Food and Drug Administration), CDRH (Center for Devices and Radiological Health), GHTF (Global Harmonization Task Force), IEC and the International Organization for Standardization (ISO), but giving a Risk-free product which will meet the intended purpose is an ethical binding for medical device companies.

BE Analytic will help companies develop world class medical devices while meeting all the requirements.

The objective of SSA is to identify hazard and preliminary risk that contributes to and interaction of the subsystems to system hazards. Assessing the results of design and implementation and ensuring that all safety requirements are met.

Risk identification and Analysis

  • FMEA (Failure Mode and Effects Analysis)
  • Fault Tree analysis
  • Study of past history or similar products

Risk Estimation

  • FMEA (Failure Mode and Effects Analysis)
  • Fault Tree analysis
  • Reliability prediction(MTBF) and System modelling(RBD)

Risk Control Measures: Analyze

  • FMEA (Failure Mode and Effects Analysis)
  • Reliability prediction(MTBF)
  • System modelling(RBD)
  • Reliability Testing

Production and Field Reliability

  • FRACAS(Failure Reporting, Analysis and Corrective Action System)
  • Weibull analysis
  • Cost of Failure and Warranty

The competition in the medical industry increasing day by day, and inventing new and fast is the trend, but it should not compromise on technology (design aspects) and the production process for building a better system which includes mechanical, electronics and software must meet the Reliability requirements. Reliability should not be evaluated at the end of production but taken care of and ensured that the product will meet Reliability. The best way to do this is by implementing DFR (Design for Reliability) i.e. set the target at the concept stage and keep monitoring and controlling till we achieve it in the field when it is deployed.

BE Analytic is capable of implementing DFR and also has a working knowledge of different industry standards ISO 14971, IEC 60601, ISO/TR 80002, IEC 62304, 21 CFR Part 11, Verification and Validation by providing different testing services, please deck our testing services leaflet for more info.

Engineering product testing to meet the necessary compliances and to validate the Design and Life/ Warranty is done. We are involved right from designing a test I test cases to check the robustness by considering use/ misuse/ abuse and different environmental conditions. Designing an Accelerated Life Test (ALT) and Highly Accelerated Life Test (HALT) is an art, in which BE Analytic is known for its expertise. Check our test capabilities for more info.