Keystone Compliance
★★★★★
4.8
/ 5
•
20 reviews
Keystone Compliance offers specialized EMC testing for medical devices, ensuring compliance with industry standards. They provide expert services to help manufacturers navigate complex regulatory requirements.
Keystone Compliance is a dedicated provider of Electromagnetic Compatibility (EMC) testing services, specifically tailored for the medical device industry. They understand the critical nature of compliance for medical equipment and offer comprehensive testing solutions to ensure devices meet stringent regulatory standards. Their expertise in EMC testing helps manufacturers identify and mitigate potential electromagnetic interference issues, which is crucial for patient safety and device reliability. By partnering with Keystone Compliance, medical device companies can streamline their product development process and gain confidence in their product's market readiness. The company focuses on delivering accurate and reliable testing results, supported by a team of experienced professionals. They are committed to assisting clients in achieving compliance with relevant national and international regulations, facilitating smoother market access for innovative medical technologies.
About
**Who they are**
Keystone Compliance is a full-service regulatory compliance laboratory specializing in EMC/EMI, environmental, and package testing. They focus on providing expert solutions for manufacturers navigating complex regulatory requirements.
**Expertise & scope**
* Specializes in EMC/EMI testing for medical devices, ensuring compliance with industry standards like IEC 60601.
* Offers electrical safety, mechanical safety, and thermal safety testing for medical equipment.
* Provides testing for a broad range of products including medical devices, household appliances, lighting products, IT and security equipment, and batteries.
* Expertise includes cybersecurity testing for the Radio Equipment Directive (RED) and EU Cyber Resilience Act (CRA).
* Capabilities extend to commercial, military, and country-specific testing, as well as wireless certification.
**Reputation / proof points**
* Accredited laboratory with a staff of engineers and report writers.
* Facility includes multiple anechoic/ferrite lined 3-meter chambers and various environmental test equipment.
* Accredited by the International Safe Transit Association (ISTA) for package testing.
* Accredited to ISO/IEC 17025:2005 by the American Association for Laboratory Accreditation (A2LA) for electrical and mechanical scopes.
* Accredited by the Freight Classification Development Council (FCDC).
* Multiple office locations: New Castle, PA; Madison Heights, MI; and Durham, NC.
Keystone Compliance is a full-service regulatory compliance laboratory specializing in EMC/EMI, environmental, and package testing. They focus on providing expert solutions for manufacturers navigating complex regulatory requirements.
**Expertise & scope**
* Specializes in EMC/EMI testing for medical devices, ensuring compliance with industry standards like IEC 60601.
* Offers electrical safety, mechanical safety, and thermal safety testing for medical equipment.
* Provides testing for a broad range of products including medical devices, household appliances, lighting products, IT and security equipment, and batteries.
* Expertise includes cybersecurity testing for the Radio Equipment Directive (RED) and EU Cyber Resilience Act (CRA).
* Capabilities extend to commercial, military, and country-specific testing, as well as wireless certification.
**Reputation / proof points**
* Accredited laboratory with a staff of engineers and report writers.
* Facility includes multiple anechoic/ferrite lined 3-meter chambers and various environmental test equipment.
* Accredited by the International Safe Transit Association (ISTA) for package testing.
* Accredited to ISO/IEC 17025:2005 by the American Association for Laboratory Accreditation (A2LA) for electrical and mechanical scopes.
* Accredited by the Freight Classification Development Council (FCDC).
* Multiple office locations: New Castle, PA; Madison Heights, MI; and Durham, NC.
Additional information
Keystone Compliance emphasizes a customer-centric approach, prioritizing engineer-to-engineer communication and providing detailed reports with quick turnaround times. Their facility is designed for customer comfort, featuring a spacious lounge with individual workstations and WIFI. They assist in determining which specific standards apply to a device and map out all general, collateral, and particular requirements during test planning to ensure a complete evaluation. This proactive approach helps manufacturers identify and address potential design flaws or safety issues before formal compliance testing.
Key Highlights
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Specializes in IEC 60601 medical device testing, covering electrical, mechanical, and thermal safety.
Source
“Manufacturers of medical electrical equipment must adhere to IEC 60601 standards to ensure their devices are safe and effective for use.”
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Offers comprehensive EMC/EMI testing, including radiated and conducted emissions, and immunity testing.
Source
“Electromagnetic compatibility (EMC) testing evaluates a device or system’s ability to operate correctly in its intended electromagnetic environment without emitting intolerable electromagnetic interference (EMI)”
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Accredited to ISO/IEC 17025:2005 by A2LA for both electrical and mechanical scopes.
Source
“Keystone Compliance is accredited to ISO/IEC 17025:2005 by the American Association for Laboratory Accreditation (A2LA) for both electrical and mechanical scopes.”
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Provides cybersecurity testing for the Radio Equipment Directive (RED) and EU Cyber Resilience Act (CRA).
Source
“EN 18031 Cybersecurity Testing for the Radio Equipment Directive (RED)”
Certifications & Trust Signals
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Accredited by the International Safe Transit Association (ISTA) for package testing.
Source
“Keystone Compliance is accredited by the International Safe Transit Association (ISTA) to complete its package testing procedures.”
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Accredited by the Freight Classification Development Council (FCDC).
Source
“Additionally, Keystone is accredited by the Freight Classification Development Council (FCDC)”
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Operates multiple testing facilities across the United States.
Source
“131 N. Columbus InnerbeltNew Castle, PA 16101 203 Commerce AvenueNew Castle, PA 16101 32201 North Avis DriveMadison Heights, MI 48071 2320 Presidential DriveSuite 101Durham, NC 27703”
Buyer Snapshot
Best for
- Manufacturers of medical electrical equipment requiring IEC 60601 compliance.
- Companies needing EMC/EMI testing for product acceptance in global markets.
- Businesses seeking accredited testing for package integrity and distribution.
How engagement typically works
- Engineer-to-engineer communication.
- Proactive technical feedback and detailed reporting.
- Collaborative test planning to ensure comprehensive evaluation.
Typical deliverables
- IEC 60601 safety and performance test reports.
- EMC/EMI compliance test reports.
- Package testing reports (ISTA certified).
- Cybersecurity compliance reports.
Good to know
- Best when clear product specifications and intended use are available.
- Best when manufacturers are prepared to address any identified non-compliance issues.
Pricing
Model:
Per project
HQ:
New Castle, US
Languages:
English
Timezones:
EST
Claim status:
Listed
Services & Capabilities
Electrical Safety + EMC Testing (IEC 60601)
Countries:
United States, Canada, Europe, Asia
Industries:
Medical Devices
Pricing model:
Per project
Standards Supported:
IEC 60601-1, IEC 60601-1-2, IEC 60601-1-2 Ed. 4, IEC 60601-1-11, ISO/IEC 17025
Test Coverage:
Both
Is Accredited:
Yes
Accreditation Body:
A2LA
Accreditation Certificate Number:
9939-1
Accreditation Scope Document Url:
https://www.a2la.org/scopepdf/9939-1.pdf
Nrtl Relationships:
UL, TUV, Intertek, CSA
Cb Scheme Support:
Yes
Max Eut Size:
Large
Max Eut Weight:
10000
Chamber Type:
Semi-anechoic
Frequency Range:
9 kHz to 40 GHz
Pre Scan Debug Support:
Yes
On Site Testing Option:
Yes
Wireless Add On Capability:
Yes
Lead Time Band:
Start in 0-2 weeks
Quote SLA:
< 24 hours
Rush Available:
Yes
Test Types Offered:
Conducted emissions, Radiated emissions, ESD immunity, EFT immunity, Surge immunity, RF immunity, Dips/interruptions, Voltage variations
Regions Served:
North America, Europe, Asia, Global
Sample Return Policy:
Return
Nda Support:
Yes
Minimum Project Size:
$10-25k
Additional medical_device_emc_testing Details
Standards Supported
IEC 60601, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, EN 18031, RED, CRA, ISTA
Test Coverage
Both, EMC only, EMC, Safety
Nrtl Relationships
N/A
Max Eut Size
N/A
Chamber Type
Anechoic
Lead Time Band
N/A
Quote SLA
N/A
Test Types Offered
EMC/EMI Compliance Testing, Lightning & Surge Testing, Shielding Effectiveness, Electrostatic Discharge Testing (ESD), Electrical Safety, Mechanical Safety, Thermal Safety, Fire Resistance, Software Verification and Validation, Package Testing
Sample Return Policy
N/A
Minimum Project Size
N/A
Pricing Model
Per project
