PSN Labs
Verified
PSN Labs is a full-service engineering partner specializing in medical device EMC testing, design, development, and manufacturing. They offer end-to-end solutions from concept to market, ensuring product safety and regulatory compliance.
PSN Labs is a comprehensive engineering partner with a strong focus on the medical device industry, offering specialized services in EMC testing, design, development, and manufacturing. Their state-of-the-art Testing Laboratory is ISO/IEC 17025:2017 accredited, ensuring accurate and reliable data for a wide range of material and product testing needs. They provide end-to-end engineering services, guiding products from initial concept through to market launch, with a particular emphasis on biocompatibility and toxicology. With an ISO 13485 certified engineering lab, PSN Labs is equipped to handle the entire product realization process, from early-stage design to final validation. They offer customized testing solutions, including custom test method development, functional device testing, and design verification testing, often collaborating with their accredited test lab. Their expertise extends to material science, helping clients select and process materials for optimal performance and safety, and they are adept at navigating complex regulatory landscapes, including FDA submissions and 510(k) clearance. PSN Labs prides itself on being more than just a testing facility; they are a development partner that provides in-depth analysis and realistic solutions. Their team of material scientists, toxicologists, and engineers work collaboratively to solve complex design, material, and manufacturing challenges, ensuring devices meet both performance and regulatory requirements. They are committed to patient safety and regulatory compliance, making them a trusted resource for medical device manufacturers.
About
**Who they are**
PSN Labs is a full-service engineering partner specializing in medical device EMC testing, design, development, and manufacturing. They offer end-to-end solutions from concept to market, ensuring product safety and regulatory compliance.
**Expertise & scope**
* Full-service engineering partner for medical device EMC testing, design, development, and manufacturing.
* End-to-end solutions from concept to market.
* Specializes in material science, including custom material compounds, Liquid Silicone Rubber (LSR) processing, and material selection for specific applications and environments.
* Offers comprehensive testing services, including Analytical, Physical, Rheological, Thermal, Electrical, Biocompatibility, Toxicology, and Mechanical testing.
* Provides engineering support, acting as an extended engineering department for clients, offering expert witness services, and training sessions.
* Focuses on biocompatibility in medical device manufacturing, assisting with regulatory changes and 510(k) clearance submissions.
* Develops custom test methods for mechanical, electrical, environmental, and packaging parameters.
**Reputation / proof points**
* ISO/IEC 17025:2017 accredited Testing Laboratory.
* ISO 13485 certified engineering lab for the design and development of medical device components.
PSN Labs is a full-service engineering partner specializing in medical device EMC testing, design, development, and manufacturing. They offer end-to-end solutions from concept to market, ensuring product safety and regulatory compliance.
**Expertise & scope**
* Full-service engineering partner for medical device EMC testing, design, development, and manufacturing.
* End-to-end solutions from concept to market.
* Specializes in material science, including custom material compounds, Liquid Silicone Rubber (LSR) processing, and material selection for specific applications and environments.
* Offers comprehensive testing services, including Analytical, Physical, Rheological, Thermal, Electrical, Biocompatibility, Toxicology, and Mechanical testing.
* Provides engineering support, acting as an extended engineering department for clients, offering expert witness services, and training sessions.
* Focuses on biocompatibility in medical device manufacturing, assisting with regulatory changes and 510(k) clearance submissions.
* Develops custom test methods for mechanical, electrical, environmental, and packaging parameters.
**Reputation / proof points**
* ISO/IEC 17025:2017 accredited Testing Laboratory.
* ISO 13485 certified engineering lab for the design and development of medical device components.
Additional information
PSN Labs integrates its Engineering Design Center, Material Testing Lab, and Processing Lab within the same facility, enabling a cohesive, full-service approach to product development. This interconnectedness facilitates rapid prototyping, virtual design cycles, and rigorous testing. They emphasize providing analysis of test data to explain its implications for a product's application and performance, going beyond just raw data. Clients can leverage PSN Labs as their engineering department, benefiting from flexible arrangements and access to a broad base of expertise. The company also offers specialized services such as expert witness testimony in plastic industry-related cases and tailored training sessions.
Key Highlights
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Operates an ISO/IEC 17025:2017 accredited Testing Laboratory.
Source
“Our state-of-the-art Testing Laboratory is ISO/IEC 17025:2017 accredited and fully equipped to support all your material and product testing needs.”
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Offers end-to-end engineering services for medical devices, from concept to market.
Source
“At PSN Labs, our integrated product development process is designed to take your device from concept to market with efficiency and precision.”
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Specializes in custom material solutions, including Liquid Silicone Rubber (LSR) processing.
Source
“Liquid Silicone Rubber is used an a wide variety of applications due to its biocompatibility and durability...”
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Provides engineering support, acting as a client's engineering department.
Source
“Rely on us to be your Engineering Department.”
Certifications & Trust Signals
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Holds ISO 13485 certification for medical device component design and development.
Source
“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.”
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Participates in ASTM Proficiency Testing to ensure data accuracy.
Source
“We hold ourselves to the highest standards, regularly participating in ASTM Proficiency Testing to ensure our data is accurate every single time.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking end-to-end engineering and testing solutions.
- Companies needing specialized material science expertise for product development.
- Businesses requiring regulatory compliance support, including biocompatibility and EMC testing.
How engagement typically works
- Collaborative, acting as an extension of the client's engineering team.
- Flexible engagement models to suit business needs.
- Data-driven with a focus on providing actionable analysis.
Typical deliverables
- EMC testing reports
- Biocompatibility and toxicology reports
- Custom material formulations
- Prototypes and production-ready components
- Engineering design documentation
- Custom test method development
Good to know
- Best when requiring integrated services from design to market.
- Best when needing specialized material science and processing capabilities.
- Best when requiring ISO/IEC 17025 accredited testing.
HQ:
Erie, US
Website:
psnlabs.com
Public email:
info@psnlabs.com
Phone:
814) 464-0790
Languages:
English
Timezones:
EST
Access:
Verified
Claim status:
Listed
Services & Capabilities
Electrical Safety + EMC Testing (IEC 60601)
Pricing model:
Custom pricing
Standards Supported:
ISO/IEC 17025
Test Coverage:
Both
Is Accredited:
Yes
Accreditation Body:
ISO
Cb Scheme Support:
No
Pre Scan Debug Support:
Yes
On Site Testing Option:
No
Wireless Add On Capability:
No
Rush Available:
Yes
Nda Support:
Yes
Minimum Project Size:
No minimum
Max Eut Size:
Custom
Chamber Type:
Anechoic
Lead Time Band:
Start in 0-2 weeks
Quote SLA:
< 24 hours
Test Types Offered:
Conducted emissions, Radiated emissions, ESD immunity, EFT immunity, Surge immunity, RF immunity
Regions Served:
Global
Sample Return Policy:
Return
biocompatibility_testing
Additional medical_device_emc_testing Details
Standards Supported
IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO/IEC 17025, ISO 13485
Test Coverage
Both, Safety, EMC, Biocompatibility, Material Testing, Electrical Testing
Test Types Offered
Analytical Testing, Physical Testing, Rheological Testing, Thermal Testing, Electrical Testing, Biocompatibility and Toxicology, Mechanical Testing, Custom Test Method Development
Pricing Model
Custom
