F2 Labs
F2 Labs is a product compliance and certification testing lab with over 30 years of experience. They specialize in EMC, EMI, and electrical safety testing for medical devices, ensuring products meet global regulatory standards.
With over 30 years of experience, F2 Labs is a trusted partner in comprehensive product compliance and certification testing. They specialize in ensuring medical devices meet global regulatory requirements, including FCC, FDA, ISED, CE, UL, and CSA standards. F2 Labs offers expert testing services for IEC 60601-1 and IEC 60601-1-2, covering electrical safety, electromagnetic compatibility (EMC), and electromagnetic interference (EMI). Their services ensure products operate as intended in their intended environment and do not interfere with other devices, crucial for patient safety and market access. Beyond testing, F2 Labs provides expert consulting to guide clients through the entire product certification process. They are equipped to test a wide range of electrical products, from battery chargers to medical electrical equipment and wireless devices, providing reliable results with precision and efficiency. Clients praise their responsiveness, thoroughness, and ability to guide them through complex certification processes.
About
**Who they are**
F2 Labs is a product compliance and certification testing lab with over 30 years of experience, specializing in EMC and electrical safety testing for medical devices. They are an A2LA accredited laboratory equipped to test and approve products for various organizational and governmental certifications.
**Expertise & scope**
* Specializes in EMC, EMI, and electrical safety testing for medical devices.
* Offers testing for CE Mark, FCC, ISED Canada, IEC, UL (United States), and CSA (Canadian) NRTL certifications.
* Provides testing aligned with IEC 60601-1 and IEC 60601-1-2 standards, including the 4th edition.
* Assists with collateral standards such as IEC 60601-1-11 for home healthcare, IEC 60601-1-6 for usability, and IEC 60601-1-8 for alarms.
* Supports risk management compliance with ISO 14971.
* Offers FDA 510(k) EMC testing and documentation support, acting as an FDA ASCA accredited lab.
* Performs testing for common EM emitters relevant to FDA requirements.
* Provides consulting and educational services related to product compliance.
* Capabilities include on-site testing and testing at their facility with a 10m anechoic chamber.
**Reputation / proof points**
* Over 30 years of experience.
* A2LA accredited lab.
* ISO 17025 accredited medical device testing lab.
* FDA ASCA accredited lab.
F2 Labs is a product compliance and certification testing lab with over 30 years of experience, specializing in EMC and electrical safety testing for medical devices. They are an A2LA accredited laboratory equipped to test and approve products for various organizational and governmental certifications.
**Expertise & scope**
* Specializes in EMC, EMI, and electrical safety testing for medical devices.
* Offers testing for CE Mark, FCC, ISED Canada, IEC, UL (United States), and CSA (Canadian) NRTL certifications.
* Provides testing aligned with IEC 60601-1 and IEC 60601-1-2 standards, including the 4th edition.
* Assists with collateral standards such as IEC 60601-1-11 for home healthcare, IEC 60601-1-6 for usability, and IEC 60601-1-8 for alarms.
* Supports risk management compliance with ISO 14971.
* Offers FDA 510(k) EMC testing and documentation support, acting as an FDA ASCA accredited lab.
* Performs testing for common EM emitters relevant to FDA requirements.
* Provides consulting and educational services related to product compliance.
* Capabilities include on-site testing and testing at their facility with a 10m anechoic chamber.
**Reputation / proof points**
* Over 30 years of experience.
* A2LA accredited lab.
* ISO 17025 accredited medical device testing lab.
* FDA ASCA accredited lab.
Additional information
F2 Labs emphasizes the importance of understanding the latest standard revisions, particularly for IEC 60601-1-2 4th edition, which introduced significant technical and documentation changes. They highlight that failure to meet these new requirements can lead to costly delays in product launch. The lab can help manufacturers determine which version of a standard applies to their product and navigate the complexities of electromagnetic disturbances in various intended use environments, including professional healthcare facilities, home healthcare settings, and special environments. Their integrated approach to electrical safety and EMC testing aims to streamline the compliance process for medical devices.
Key Highlights
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Over 30 years of experience in product compliance and certification testing.
Source
“F2 Labs is an accredited regulatory testing laboratory with more than 30 years of experience performing EMC and Safety evaluations on an extensive range of products.”
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A2LA accredited laboratory for product compliance testing.
Source
“We are an A2LA accredited lab that is fully equipped to test and approve products and equipment for a wide variety of organizational and governmental certifications.”
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Specializes in IEC 60601-1 and IEC 60601-1-2 testing for medical devices.
Source
“IEC 60601-1-2 – 4th edition – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests.”
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FDA ASCA accredited lab providing medical device EMC testing and 510(k) support.
Source
“As an ISO 17025 medical device testing lab and FDA ASCA accredited lab, we provide defensible data, streamlined project timelines, and submission-ready documentation for FDA 510(k) EMC testing...”
Certifications & Trust Signals
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A2LA Accredited Laboratory
Source
“We are an A2LA accredited lab that is fully equipped to test and approve products and equipment for a wide variety of organizational and governmental certifications.”
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ISO 17025 Accredited Medical Device Testing Lab
Source
“As an ISO 17025 medical device testing lab and FDA ASCA accredited lab, we provide defensible data, streamlined project timelines, and submission-ready documentation...”
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FDA ASCA Accredited Lab
Source
“As an FDA ASCA accredited lab, our reports are structured to reduce review cycles, minimize deficiencies, and support faster clearance.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking IEC 60601 compliance.
- Companies requiring EMC and electrical safety testing for global market access.
- Clients needing FDA 510(k) EMC testing and documentation support.
How engagement typically works
- Offers both on-site and in-lab testing services.
- Provides consulting and educational services to support the compliance process.
- Focuses on delivering submission-ready documentation.
Typical deliverables
- Accredited EMC and electrical safety test reports.
- IEC 60601-1 and IEC 60601-1-2 compliance verification.
- FDA 510(k) submission documentation.
- Pre-compliance testing and risk reduction services.
Good to know
- Best when clients require specialized testing for medical electrical equipment.
- Best when clients need to navigate complex international standards like IEC 60601.
HQ:
Location Testing, US
Languages:
English
Timezones:
EST
Claim status:
Listed
Services & Capabilities
Electrical Safety + EMC Testing (IEC 60601)
Pricing model:
Per project
Standards Supported:
IEC 60601-1, IEC 60601-1-2, IEC 60601-1-2 Ed. 4, IEC 60601-1-11
Test Coverage:
Both
Nrtl Relationships:
UL, CSA
Max Eut Size:
Custom
Max Eut Size Custom:
Medical electrical equipment and wireless devices
Chamber Type:
Anechoic
Pre Scan Debug Support:
Yes
On Site Testing Option:
Yes
Wireless Add On Capability:
Yes
Test Types Offered:
Conducted emissions, Radiated emissions, ESD immunity, EFT immunity, Surge immunity, RF immunity
Regions Served:
United States, Canada, Europe, Australia/New Zealand, Korea
Nda Support:
Yes
Is Accredited:
Yes
Accreditation Body:
FDA ASCA
Cb Scheme Support:
No
Rush Available:
Yes
Minimum Project Size:
No minimum
wireless_rf_testing
Additional medical_device_emc_testing Details
Standards Supported
IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-1-6, IEC 60601-1-8, ISO 14971, CE Mark, FCC, ISED Canada, UL, CSA
Test Coverage
Both
Nrtl Relationships
UL, CSA
Chamber Type
Anechoic
Test Types Offered
EMC testing, EMI testing, Electrical safety testing, RF emissions testing, RF immunity testing, Common EM Emitters Testing
Pricing Model
Per project
