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ISO 13485:2016 & ISO 9001:2015 Certified

        Medical Technologies

        3rd Party Review

        Stress Engineering Services’s (SES) consulting engineers and scientists, with a combined 100+ years of product design experience, are able to perform independent product reviews to identify design problems prior to product release.  Reviews at all stages of product design minimize risk and reveal problems early in the development process when design changes can be made with less cost and schedule impact.  SES has identified review packages, which are built around providing guidance at critical times in the product development process.  All of SES’s reviews focus on developing an understanding of the basic science behind the function of the product.  This may include mechanism kinematics, component stresses and strains, and material behavior such as creep, relaxation and fatigue.

        Design reviews serve a key need in the product design process by ensuring that unintended product limitations or even outright mistakes are found prior to final manufacture and launch of a product.  Independent third party reviews are an important part of the design review process because they allow an unbiased technical resource to evaluate a design and identify potential problems.  Using an unbiased source is a significant part of the review process because it eliminates potential conflict-of-interest with the product design team when performing the review.

        A third party review is often thought of as ‘another engineer to attend my design review meeting’.  Although this is certainly one type of review function, there are other types of reviews that can provide meaningful feedback to the product designers at different stages of the product development process.  Targeted review services that SES offers:

        Early Stage Design Reviews are based on client-supplied product concepts.  Using this preliminary information, SES offers recommendations regarding product functionality, manufacturability and cost-effectiveness.  This early stage design review sometimes includes an on-site briefing with the client’s development staff.  SES assists clients in refining the device design requirements, ensuring that they are quantifiable. 

        Design Feedback Reviews are in-depth reviews conducted by the SES team. These often include engineering analysis of the design approach and experimental verification of components and sub-assemblies.  SES works with the client’s development team and quality group to examine/establish quality procedures, manufacturing approach and product reliability.  This is not an independent review activity, but is instead a direct involvement with the product development team

        Formal Design Reviews which must include an independent third party.  If we have been involved throughout the development process, this phase is typically more of a confirmation that all issues have been addressed, as opposed to the start of major re-design.  If we have not been involved in the development process SES is available as an independent third party reviewer.  In this instance, SES looks at all aspects of the design including: client design requirements, FDA requirements, quality procedures and the device itself.

        3rd Party Review

        3rd Party Review