Systems Engineering

Systems engineering is incredibly important and needs to be implemented from the start. It’s the guide for the overall design and maintenance of the product and there are many aspects that each play a critical part. Invetech specializes in understanding each of these parts as well as the client’s needs to ensure that our product easily “plugs into” their needs and meets the users at their level.

Why Invetech?

There are key factors that make Invetech stand out against other engineering firms:

System Architecture

We focus on the functional design of a system, including its components and their relationships to each other and to the system as a whole. A well-defined architecture helps ensure that all parts work together seamlessly and are highly efficient and cost-effective.

Automating IVD Workflows

Invetech has decades of experience in many areas of IVD, such as immunoassays, staining, and more. We specialize in automating IVD workflows for our clients to increase efficiency, accuracy, scalability, safety, and optimize resources. Our team can test and automate quickly and in-house with existing hardware. We have the scientists and the reference equipment to de-risk assay automation.

Product Definition

When needed, we have this expertise. Invetech focuses on defining and managing requirements using Functional Analysis and Technology Readiness Assessments to develop new product designs.

Risk and Hazard Analysis

In order to support successful ISO14971 (risk management) submissions, Invetech utilizes tools and processes such as dFMEA (design failure mode and effects analysis), pFMEA (process failure mode and effects analysis), Technical Review and HRA (hazard review and analysis). Our team is highly trained on each of these and can ensure that products are reliable and safe.

Substance Regulations

Invetech utilizes RoHS (restriction of hazardous substances) & REACH (registration, evaluation, authorization, and restriction of chemicals) when engineering systems. RoHS is used to limit the use of hazardous substances used in systems that could be harmful to humans and/or the environment. We rely on REACH to ensure that our team is using chemicals with high safety standards. Our team has extensive experience in regulatory standards across many countries.

Integration

Invetech uses cross-functional expertise to integrate hardware and software seamlessly. Our team is skilled and comfortable in working with external teams to manage integration with multiple parties. For example, Invetech uses software such as JIRA to track manage system defects, ensuring that any issues are identified and reported immediately.

Verification

Verification is a critical step in systems engineering that we take very seriously. Invetech excels in safety assurance, compliance, and confirmation of performance. Our verification preparation starts during the initial prototyping stages. We stride to make the process smooth and streamlined during the formal verification of requirements.

Technical Review

Invetech specializes in technical reviews - focusing in on performance margin analysis, OEM (original equipment manufacturer) assessment, and reliability assessment. We lean on our in-house engineers who have years of subject matter experience. Our experts' knowledge and experience reduces risk from the beginning.

Process

Invetech follows a specific process for all
Systems Engineering projects. We call it the “V” model.
Here’s the V model broken down by steps:

Step 1

Concept of Operations:
A high-level blueprint to align scientists,
management, and operations teams—on the project’s objectives, resources, and operational flow.

Step 2

Requirements & Architecture:
Ensure that projects meet regulatory standards,
function as intended, and fulfill specific user & market needs.

Step 3

Detailed Design:
Dive deep into the technicalities, outlining exactly how each component of a product will be manufactured, configured, and operated. The goal is to create a precise, comprehensive blueprint that guides the development process.

Step 4

Integration, Testing, and Verification:
Ensure that the system/process functions as intended and meets regulatory and quality standards.

Step 5

Sustaining Engineering:
Managing obsoleteness and cost-down activities
in our regulated field.

"Systems engineering requires a very broad skillset from system engineers - detail-minded people with a high level of attention to detail and who are experienced big picture thinkers. These people are hard to find, but we have them at Invetech!"

"We have a broad range of experience in many disciplines, which allows us to effectively leverage our subject matter experts when needed. This allows us to develop meaningful requirements with a strong understanding of the techniques and methods that can be utilized to meet our client’s needs. We focus on identifying areas of significant risk, and providing a risk based approach to tackle especially challenging requirements."

Systems Engineering

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