End-to-End Engineering Services

Comprehensive Engineering Support—Every Phase, Every Detail

At PSN Labs, our integrated product development process is designed to take your device from concept to market with efficiency and precision. With an ISO 13485 certified engineering lab for the design and development of medical device components, we ensure that quality and compliance are built into every stage of the process. Our engineering services cover every step of product realization from early-stage design to final validation so your products meet both performance and regulatory requirements.

Our Integrated Product Development Process

Our comprehensive approach to engineering centers on a process known as Integrated Product Development (IPD). Our process includes but is not limited to:

• Design for Compliance: Begin development with regulatory readiness from day one.
• Design for Manufacturability & Assembly (DfMA): Create scalable, cost-effective solutions that are simple to produce.
• Design for Reliability & Safety: Ensure robust performance under real-world conditions.
• Design for Commercialization: Balance cost, performance, and scalability to deliver market-ready products.
• Design for Biocompatibility: Optimize materials and processes early to streamline later regulatory approvals.

Throughout the process, we perform stage-gate reviews with clients and our internal teams, and maintain a complete design history file to support quality and compliance if required.

Prototyping, Testing & Validation

We combine rapid prototype iteration, virtual design cycles, rigorous testing to bring your vision to life. Our onsite functional prototyping leverages state-of-the-art capabilities, including:

Advanced Modeling & Materials Engineering

We support your product development with cutting-edge computational tools and materials expertise:

Computational Modeling & Simulation (CM&S):
Our services include regulatory-grade model development for generating verification evidence for regulatory submittals. Tools in our simulation toolbox include physics and statistical modeling approaches such as: finite element analysis (FEA), computational fluid dynamics (CFD), other multiphysics, complete digital twins, and device-level statistical modeling.

Tolerance Analysis & Model Validation:
By predicting how variability in environmental conditions, dimensional variation, material and processing conditions, usage, shelf life, or sterilization affects performance, we ensure that our models understand your variable use and manufacturing environment.

Materials Engineering & Selection:
We go beyond datasheet specifications to evaluate the mechanical, chemical, and biocompatibility properties of materials. Our application-specific material selection process supports design for biocompatibility and all other aspects of material selection from the very start.

Proactive Design for Biocompatibility Strategy:
We embed biocompatibility considerations early in the development process to reduce late-stage testing risks and to set up long-term compliance strategies.