Sigma Scientific Services LLC
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About
**Who they are**
Sigma Scientific Services LLC is a scientific and engineering group with over 30 years of experience in product development, testing, and regulatory approvals. They assist companies in navigating the complex landscape of medical device regulations.
**Expertise & scope**
* Leverage scientific, engineering, quality, compliance engineering, and regulatory resources to streamline product approval processes.
* Provide expertise in feasibility studies, rapid prototyping, product development, product testing, risk management, and software verification and validation.
* Assist in the implementation and compliance of quality management systems under good manufacturing practices.
* Offer guidance on regulatory affairs and compliance engineering.
* Support companies in the USA, Europe, Asia, and Latin America with their regulatory needs.
* Services include consulting, product testing, quality management systems, USA agent representation, establishment registration, and Unique Device Identification.
**Reputation / proof points**
* Over 30 years of experience in the field.
* Assisting companies in the USA, Europe, Asia, and Latin America.
Sigma Scientific Services LLC is a scientific and engineering group with over 30 years of experience in product development, testing, and regulatory approvals. They assist companies in navigating the complex landscape of medical device regulations.
**Expertise & scope**
* Leverage scientific, engineering, quality, compliance engineering, and regulatory resources to streamline product approval processes.
* Provide expertise in feasibility studies, rapid prototyping, product development, product testing, risk management, and software verification and validation.
* Assist in the implementation and compliance of quality management systems under good manufacturing practices.
* Offer guidance on regulatory affairs and compliance engineering.
* Support companies in the USA, Europe, Asia, and Latin America with their regulatory needs.
* Services include consulting, product testing, quality management systems, USA agent representation, establishment registration, and Unique Device Identification.
**Reputation / proof points**
* Over 30 years of experience in the field.
* Assisting companies in the USA, Europe, Asia, and Latin America.
Additional information
Sigma Scientific Services LLC focuses on making the product development, testing, and regulatory approval process more efficient and cost-effective for their clients. They emphasize their scientific and engineering capabilities to support projects requiring biomedical, software, electronics, and mechanical engineering expertise. Their services extend to advising on compliance engineering and manufacturing operations, ensuring products are developed and manufactured under good manufacturing practices. They assist in product testing and validation to demonstrate safety and effectiveness in compliance with regulations.
Key Highlights
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Over 30 years of experience in product development, testing, and regulatory approvals.
Source
“With more than 30 years of experience in the field we can assist you in your scientific and engineering projects”
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Assists companies in the USA, Europe, Asia, and Latin America with their regulatory needs.
Source
“We are assisting companies in USA, Europe, Asia and Latin America in their regulatory needs.”
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Offers services including consulting, product testing, quality management systems, USA agent representative, establishment registration, and Unique Device Identification.
Source
“Our services include consulting, product testing, quality management systems, USA agent representative, establishment registration, and Unique Device Identification between others.”
Certifications & Trust Signals
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Provides expertise in product development, testing, risk management, and software verification and validation.
Source
“Our experience includes feasibility studies, rapid prototyping, product development, product testing, risk management, software verification and validation”
Buyer Snapshot
Best for
- Companies seeking to streamline medical device product development and regulatory approval.
- Businesses needing expertise in compliance engineering and quality management systems.
How engagement typically works
- Consultative approach to regulatory strategy.
- Collaborative support for product development and testing.
Typical deliverables
- Regulatory strategy consulting.
- Product testing and validation reports.
- Quality management system implementation guidance.
- USA agent representation.
Good to know
- Best when requiring specialized scientific and engineering support for complex medical devices.
HQ:
New York, Canada
Languages:
English
Timezones:
EST
Claim status:
Listed
Services & Capabilities
Electrical Safety + EMC Testing (IEC 60601)
Countries:
Canada, Japan, Europe
Industries:
Medical Devices
Pricing model:
Custom pricing
Standards Supported:
IEC 60601-1, IEC 60601-1-2
Test Coverage:
Both
Is Accredited:
Yes
Nrtl Relationships:
UL, TUV, Intertek, CSA
Cb Scheme Support:
Yes
Max Eut Size:
Large
Chamber Type:
Semi-anechoic
Frequency Range:
20 Hz to 40 GHz
Pre Scan Debug Support:
Yes
On Site Testing Option:
Yes
Wireless Add On Capability:
Yes
Lead Time Band:
Start in 2-4 weeks
Quote SLA:
24-48 hours
Rush Available:
Yes
Test Types Offered:
Conducted emissions, Radiated emissions, ESD immunity, EFT immunity, Surge immunity, RF immunity, Dips/interruptions
Regions Served:
North America, Europe, Asia
Sample Return Policy:
Return
Nda Support:
Yes
Accreditation Body:
A2LA
Accreditation Certificate Number:
99396
Minimum Project Size:
$10-25k
Additional medical_device_emc_testing Details
Standards Supported
IEC 60601
Test Coverage
EMC, Safety, Both
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
Ultrasound Testing, Transducer Validation
Sample Return Policy
N/A
Minimum Project Size
N/A
Pricing Model
N/A
