Medical Device - Reliability & Risk Assessment

Medical Device - Reliability & Risk Assessment

In medical industry it is a challenge to develop a Safe, Reliable product at the same time ensuring the effective end application meeting all its requirements. These three aspects are not just requirements which are necessary to meet and satisfy the regulatory agencies like FDA (Federal Food and Drug Administration’s), 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 a ethical binding for medical device companies.

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

The objective of SSA is to identifying hazard and preliminary risk that contributes 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 & analysis

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

Risk Estimation

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

Risk Control Measures: Analyze

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

Production & Field Reliability

  • FRACAS(Failure Reporting, Analysis and Corrective Action System)
  • Weibull analysis
  • Cost of Failure & Warranty
The competition in the medical industry increasing day by day, invent new and invent 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 working knowledge on 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 involve 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, where BE Analytic is known for its expertise. Check our test capabilities for more info.