Reliability, Safety, Risk and Environmental services for Medical Devices

Over the years there has been significant increase in the amount of Electric, Electronics, Software and Electro-Mechanical systems across different range of Medical Devices. Future of Medical Device business lies in Advanced, Safe, Reliable Medical Devices which fulfill the needs of more patients across the globe inline with current International and Local standards like FDA and other.

ReliaSystem have in depth experience in working on advanced medical devices from top medical OEM’s in USA and INDIA like Medtronic, GE and Covidien. At ReliaSystem we work with your team to identify all Reliability, Safety, Risk, and Environmental requirements, perform all the activities required to ensure that the system will meet stringent requirements inline with US FDA, local and product specific compliances for Surgical, Respiratory, Vascular, Patient monitoring devices etc.

Reliability Engineering Services :

  • Reliability Goal setting and Project planning at Product and Subsystem level
  • Supplier/Component selection and Validation
  • Derating Analysis and Reliability Prediction
  • Reliability Test Protocol Design & Execution
  • HALT,ALT,RGT and Thermal Test
  • Product & Subsystem Reliability assessments
  • Field failure & Warranty analysis .
  • Reliability Certifications
  • Reliability Standards - Prediction: MIL-HDBK-217Fn2, Telcordia SR 332 Issue 3, IEC 62380 (RDF), FMEA: IEC 60812 etc

Safety and Risk Management Services

  • Safety and Risk management Plan
  • Safety & Risk Analysis
         • DFMEA     
         • PFMEA    
         • System/Subsystem Hazard Analysis
         • Risk Estimation
         • Risk Control
  • Development and Execution of Single Fault safety and Risk Management verification analysis Protocols and Reports.
  • Safety Certification
  • Standards: Safety Analysis: IEC 60601-1 , • 80601-1 & sub clauses, PVHO-1-2007, AAMI / ANSI / IEC 60601-2-27:2011., Risk Management: IEC 60601-1, IEC 60601-2, ISO 13485, ISO 14971. etc

Environmental Services

  • EMC Assurance Plan
  • Product Environmental requirements identification and analysis
  • Design & Development Environmental Test protocols
  • Test Fixture Design and Test Automation
  • Execution and Root cause analysis
  • Test reports and required suggestion for design improvements
  • Standards: Product Specific Environmental standards
  • Certifications

RCM and Asset Management services for Energy Industry

Time is money for Energy and petrochemical industry. Failures and repair time increases, profit decreases. Maintenance and asset management is important to optimize the maintenance duration and cost. Reliasystem Experienced Reliability Engineers work with the customers to maximize the system availability, reduce the operational cost , maintenance cost and duration. Reliasystem follows all the international Safety, RCM and Asset management standards.

RAMS Assurance Services :

  • RAMS Requirement
  • RAMS modeling
  • Reliability Centered Maintenance (RCM)
  • Asset Management
  • Condition based maintenance analysis
  • Failure prediction models
  • FRACAS system development and maintenance
  • Data collection and reporting
  • Spare part management