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 provider that partners with manufacturers to meet their regulatory compliance test needs.

**Expertise & scope**
* Electrical Safety Testing
* EMC Testing (IEC 60601)

**Reputation / proof points**
* Over 150 different manufacturers partnered with them last year.

Additional information

Keystone Compliance offers specialized EMC testing services tailored for medical devices. Their expertise lies in guiding manufacturers through the intricate process of ensuring compliance with relevant industry standards. This focus helps clients navigate complex regulatory requirements effectively.

Key Highlights

  • Over 150 manufacturers partnered with Keystone Compliance last year for regulatory compliance testing. Source
    “Last Year Over 150 Different Manufacturers Partnered With Keystone Compliance To Meet Their Regulatory Compliance Test Needs.”

Certifications & Trust Signals

  • Accredited by the American Association for Laboratory Accreditation (A2LA) to ISO/IEC 17025:2005. Source
    “The A2LA accreditation signifies that Keystone Compliance has met strict technical competency requirements and quality management system requirements.”
  • Accredited by the International Safe Transit Association (ISTA) for package testing procedures. Source
    “Keystone Compliance is accredited by the International Safe Transit Association (ISTA) to complete its package testing procedures.”
  • Accredited by the Freight Classification Development Council (FCDC). Source
    “Additionally, Keystone is accredited by the Freight Classification Development Council (FCDC) which operates under the support of the National Motor Freight Traffic Association (NMFTA).”

Buyer Snapshot

Best for
  • Medical device manufacturers seeking EMC compliance testing
How engagement typically works
  • Expert consultation on regulatory requirements
  • Specialized testing services
Typical deliverables
  • EMC test reports
  • Compliance guidance
Good to know
  • Best when specific expertise in medical device EMC testing is required.
HQ: US
Languages: English
Status: listed

Services & Capabilities

Electrical Safety + EMC Testing (IEC 60601)

Countries: United States, Canada, Europe, Asia
Industries: Medical Devices
Standards Supported: IEC 60601-1-2
Test Coverage: EMC only

Additional medical_device_emc_testing Details

Standards Supported
IEC 60601
Test Coverage
Both, EMC only
Nrtl Relationships
N/A
Max Eut Size
N/A
Chamber Type
N/A
Lead Time Band
N/A
Quote SLA
N/A
Test Types Offered
EMC testing
Sample Return Policy
N/A
Minimum Project Size
N/A
Pricing Model
N/A
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