Supporting the Hydrogen, Alternative Energy and Medical Device industries, we help companies turn their breakthrough technologies into products that are Safe, Effective, Reliable, Ready for Commercialization.

We do this by: 	
 - Identifying Industry-appropriate Technology Readiness Level (TRL) Assessment criteria and Technology Maturation, verification and Validation Test Planning
 - Building or Remediating Medical Device Risk Management Files and Design History Files to comply with the latest revisions of:  
     - US FDA 21CFR Part 820 Good Manufacturing Practices (GMP)
     - ISO 13485:2016 Quality Management Systems for Medical Devices  
     - ISO 14971:2019 Risk management for Medical Devices
     - ISO 62366:2015 Application of Human Factors to Medical Devices 
     - EU MDR 2017/745

20+ years experience commercializing New Technologies 
Alternative Energy, Natural Gas, Hydrogen & Fuel Cells: 
- design for safety and reliability (per CSA/ANSI FC1 / CSA 22.2 No. 62282)   	

25 years Design for Reliability, Availability, Maintainability and Safety (RAMS):
- Design for Reliability, Robust Engineering Design, Design for Manufacturing
- Production Part Approvals, Quality Engineering, Design Quality Assurance 
- Automotive quality management (per standard IATF16949)
- Automotive Safety-Related system analysis: Automotive Safety Integrity Level (ASIL) determination, functional safety requirements (ISO26262:2018)
- Automotive Industry Product Development and Design for Manufacturing (VDA) 

Having worked with conventional as well as cutting edge, renewable energy technologies, and in industries where safety, reliability and integrity are critical, I can work with your company to plan your product development, avoid failures, and make sure your products are Safe, Effective, Reliable, Ready - and profitable

Saegert Solutions

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