PSN Labs
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**
* ISO/IEC 17025:2017 accredited Testing Laboratory for material and product testing.
* Specializes in medical device EMC testing, design, development, and manufacturing.
* Offers customized material solutions, including material selection, custom material compounds, and processing methods.
* Provides biocompatibility and toxicology services, assisting with regulatory changes and 510(k) clearance submissions.
* Conducts various testing services: Analytical, Physical, Rheological, Thermal, Electrical, Biocompatibility and Toxicology, Mechanical, and custom test method development.
* Offers end-to-end engineering services from concept to market, including prototyping, testing, and validation.
* Provides engineering support, acting as an extension of a client's engineering department, including expert witness services and training.
**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**
* ISO/IEC 17025:2017 accredited Testing Laboratory for material and product testing.
* Specializes in medical device EMC testing, design, development, and manufacturing.
* Offers customized material solutions, including material selection, custom material compounds, and processing methods.
* Provides biocompatibility and toxicology services, assisting with regulatory changes and 510(k) clearance submissions.
* Conducts various testing services: Analytical, Physical, Rheological, Thermal, Electrical, Biocompatibility and Toxicology, Mechanical, and custom test method development.
* Offers end-to-end engineering services from concept to market, including prototyping, testing, and validation.
* Provides engineering support, acting as an extension of a client's engineering department, including expert witness services and training.
**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 a single facility, enabling a cohesive full-service approach to product development. Their material scientists and engineers possess extensive knowledge of material properties and their application-specific relevance, aiming to optimize material selection for performance, cost, and reputation. The company emphasizes providing more than just data from their testing services, offering analysis of what the data means for a product's application and performance. They also highlight their capability in developing custom materials and providing them to suppliers or molding final products in-house.
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 medical device EMC testing, design, development, and manufacturing.
Source
“PSN Labs is a full-service development partner, focusing on biocompatibility in medical device manufacturing.”
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Provides customized material solutions and processing, including Liquid Silicone Rubber (LSR) processing.
Source
“Liquid Silicone Rubber is used an a wide variety of applications due to its biocompatibility and durability...”
Certifications & Trust Signals
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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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ISO 13485 certified engineering lab for medical device components.
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.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking end-to-end engineering and testing support.
- Companies requiring specialized material development and processing.
- Businesses needing regulatory compliance assistance for medical devices.
How engagement typically works
- Collaborative, acting as an extension of the client's engineering team.
- Flexible arrangements tailored to business needs.
- Providing detailed analysis beyond raw data.
Typical deliverables
- EMC test reports and compliance documentation.
- Custom material formulations and processed materials.
- Prototypes and production-ready components.
- Biocompatibility and toxicology reports.
- Design history files and validation documentation.
Good to know
- Best when requiring integrated services from design to market.
- Best when needing specialized material science expertise.
HQ:
Erie, US
Languages:
English
Timezones:
EST
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:
No
On Site Testing Option:
No
Wireless Add On Capability:
No
Rush Available:
No
Nda Support:
No
Minimum Project Size:
No minimum
biocompatibility_testing
Additional medical_device_emc_testing Details
Standards Supported
IEC 60601, ISO/IEC 17025, ISO 13485
Test Coverage
Both, Safety, EMC, Biocompatibility, Material 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
