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**
* Full-service engineering partner for medical devices.
* Specializes in EMC testing, design, development, and manufacturing.
* Offers end-to-end solutions from concept to market.
* Provides material science expertise, including custom material compounds and processing.
* Conducts various testing services: Analytical, Physical, Rheological, Thermal, Electrical, Biocompatibility, Toxicology, and Mechanical testing.
* Develops custom test methods for mechanical, electrical, environmental, and packaging parameters.
* Focuses on biocompatibility in medical device manufacturing, assisting with regulatory changes and 510(k) clearance submissions.
* Evaluates the effect of cleaning chemicals on materials of construction for medical devices.
* Assists in manufacturing processes and materials of construction to ensure patient safety.
**Reputation / proof points**
* ISO/IEC 17025:2017 accredited Testing Laboratory.
* ISO 13485 certified engineering lab for medical device component design and development.
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 devices.
* Specializes in EMC testing, design, development, and manufacturing.
* Offers end-to-end solutions from concept to market.
* Provides material science expertise, including custom material compounds and processing.
* Conducts various testing services: Analytical, Physical, Rheological, Thermal, Electrical, Biocompatibility, Toxicology, and Mechanical testing.
* Develops custom test methods for mechanical, electrical, environmental, and packaging parameters.
* Focuses on biocompatibility in medical device manufacturing, assisting with regulatory changes and 510(k) clearance submissions.
* Evaluates the effect of cleaning chemicals on materials of construction for medical devices.
* Assists in manufacturing processes and materials of construction to ensure patient safety.
**Reputation / proof points**
* ISO/IEC 17025:2017 accredited Testing Laboratory.
* ISO 13485 certified engineering lab for medical device component design and development.
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. This interconnectedness allows for rapid prototype iteration, 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 numbers. Clients can leverage PSN Labs as their extended engineering department, benefiting from flexible arrangements and access to a broad base of expertise. The company also offers expert witness services and training sessions adapted to client needs.
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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Holds ISO 13485 certification for its engineering lab focused on 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.”
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Provides custom material solutions, including custom material compounds and processing.
Source
“Developing custom materials for a variety of applications like selective sorbent systems, conductive compounds, highly or uniquely filled materials, or even for specific tribology requirements has historically been a part of PSN’s business model.”
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Offers custom test method development for mechanical, electrical, environmental, and packaging parameters.
Source
“Custom Test Method Development:Our expert team creates methods for mechanical, electrical, environmental, packaging, and other critical testing parameters, ensuring that every aspect of device performance is evaluated.”
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.”
-
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 development support.
- Companies needing specialized material science and processing expertise.
- Providers requiring comprehensive testing services, including custom method development.
How engagement typically works
- Collaborative partnership, acting as an extension of the client's engineering team.
- Flexible arrangements tailored to business needs.
- Focus on providing data analysis and realistic solutions.
Typical deliverables
- EMC testing reports.
- Custom material compounds.
- Prototypes and production-ready parts.
- Biocompatibility and toxicology reports.
- Custom test method development plans.
- Design history files for regulatory support.
Good to know
- Best when requiring integrated services from design to market.
- Best when needing specialized material science and testing capabilities.
HQ:
Erie, US
Languages:
English
Timezones:
EST
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, IEC 61010-1, ISO/IEC 17025
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
