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 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 extension of a client's engineering department, with expertise in part and product failure analysis, patent infringement, and trade secrets.
* Conducts custom test method development 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 extension of a client's engineering department, with expertise in part and product failure analysis, patent infringement, and trade secrets.
* Conducts custom test method development 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 a single facility, enabling a cohesive 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 product application and performance, going beyond mere data delivery. Clients can leverage PSN Labs as their engineering department, benefiting from flexible arrangements and access to a broad base of expertise.
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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Specializes in custom material solutions, including Liquid Silicone Rubber (LSR) processing and custom material compounds.
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.”
Certifications & Trust Signals
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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.”
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Offers expertise in biocompatibility and toxicology for medical devices, assisting with regulatory submissions.
Source
“PSN Labs bridges the gap between the FDA and medical device manufacturers to stay on top of regulatory changes and help in your 510(k) Clearance Submissions.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking end-to-end engineering and testing solutions.
- Companies requiring specialized material science expertise for product development.
- Businesses needing to ensure product safety and regulatory compliance.
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
- Material characterization and custom formulation
- Product design and development documentation
- Biocompatibility and toxicology reports
- Custom test plans and execution
Good to know
- Best when requiring integrated services from design to market.
- Best when needing specialized material science and processing 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, ISO/IEC 17025, ISO 13485, ASTM
Test Coverage
Both, Safety, EMC, Biocompatibility, Material Testing
Test Types Offered
EMC testing, Electrical testing, Biocompatibility testing, Toxicology testing, Material testing, Mechanical testing, Rheological testing, Thermal testing
Pricing Model
Custom
