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 regulatory landscape for medical devices and other products.
**Expertise & scope**
* Leveraging scientific, engineering, quality, compliance engineering, and regulatory resources to streamline product approval processes.
* Providing expertise in feasibility studies, rapid prototyping, product development, product testing, risk management, and software verification and validation.
* Assisting with the implementation and compliance of quality management systems under good manufacturing practices.
* Offering consulting on regulatory affairs, compliance engineering, and manufacturing operations.
* Supporting companies in the USA, Europe, Asia, and Latin America with their regulatory needs, including establishment registration and acting as a US agent representative.
**Reputation / proof points**
* Over 30 years of experience in the field.
* Assists companies with product compliance and approval in the US and abroad.
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 regulatory landscape for medical devices and other products.
**Expertise & scope**
* Leveraging scientific, engineering, quality, compliance engineering, and regulatory resources to streamline product approval processes.
* Providing expertise in feasibility studies, rapid prototyping, product development, product testing, risk management, and software verification and validation.
* Assisting with the implementation and compliance of quality management systems under good manufacturing practices.
* Offering consulting on regulatory affairs, compliance engineering, and manufacturing operations.
* Supporting companies in the USA, Europe, Asia, and Latin America with their regulatory needs, including establishment registration and acting as a US agent representative.
**Reputation / proof points**
* Over 30 years of experience in the field.
* Assists companies with product compliance and approval in the US and abroad.
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 expertise in biomedical, software, electronics, and mechanical engineering. Their services extend to advising on regulatory affairs, compliance engineering, and manufacturing operations, ensuring products meet safety, efficacy, and regulatory standards. They also help companies implement and comply with quality management systems.
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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Provides consulting, product testing, quality management systems, and US agent representation.
Source
“Our services include consulting, product testing, quality management systems, USA agent representative, establishment registration”
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Assists companies in the USA, Europe, Asia, and Latin America with regulatory needs.
Source
“We are assisting companies in USA, Europe, Asia and Latin America in their regulatory needs.”
Certifications & Trust Signals
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Experience in product development, testing, and regulatory approvals.
Source
“Product development, testing and regulatory approval is a lengthy and expensive process. We are a scientific and engineering group experienced in product development and regulatory approvals.”
Buyer Snapshot
Best for
- Companies seeking assistance with medical device regulatory approvals.
- Businesses needing support with product development and testing.
- Organizations requiring guidance on quality management systems and compliance engineering.
How engagement typically works
- Consultative approach to regulatory strategy.
- Collaborative support for product development lifecycle.
- Expert guidance on compliance and manufacturing operations.
Typical deliverables
- Regulatory strategy development.
- Product testing and validation reports.
- Quality management system implementation.
- FDA US Agent services.
- Establishment registration.
Good to know
- Best when requiring specialized scientific and engineering expertise for product compliance and approval.
HQ:
Canada
Languages:
English
Status:
listed
Services & Capabilities
Electrical Safety + EMC Testing (IEC 60601)
Countries:
Canada, Japan, Europe
Industries:
Medical Devices
Pricing model:
Custom pricing
Standards Supported:
IEC 60601-1-2
Test Coverage:
EMC only
Is Accredited:
No
Cb Scheme Support:
No
Max Eut Size:
Custom
Chamber Type:
Semi-anechoic
Frequency Range:
9 kHz to 40 GHz
Pre Scan Debug Support:
No
On Site Testing Option:
No
Wireless Add On Capability:
No
Lead Time Band:
Start in 4-8 weeks
Quote SLA:
3-5 business days
Rush Available:
No
Test Types Offered:
Radiated emissions, Conducted emissions
Regions Served:
North America, Europe
Sample Return Policy:
Return
Nda Support:
Yes
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
