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 assisting companies with product development, testing, and regulatory approval. They leverage their expertise in biomedical, software, electronics, and mechanical engineering to make the regulatory process more efficient and cost-effective.
**Expertise & scope**
* Regulatory consulting and strategy development for US and international markets.
* Assistance with FDA registration and listing services.
* Product compliance and approval processes.
* Consulting on quality management systems and good manufacturing practices.
* Support for establishment registration and Unique Device Identification.
* USA agent representative services.
* Product testing, including Ultrasound Testing and Transducer Validation.
* Feasibility studies, rapid prototyping, and risk management.
* Software verification and validation.
**Reputation / proof points**
* Over 30 years of experience in the field.
* Assists 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 assisting companies with product development, testing, and regulatory approval. They leverage their expertise in biomedical, software, electronics, and mechanical engineering to make the regulatory process more efficient and cost-effective.
**Expertise & scope**
* Regulatory consulting and strategy development for US and international markets.
* Assistance with FDA registration and listing services.
* Product compliance and approval processes.
* Consulting on quality management systems and good manufacturing practices.
* Support for establishment registration and Unique Device Identification.
* USA agent representative services.
* Product testing, including Ultrasound Testing and Transducer Validation.
* Feasibility studies, rapid prototyping, and risk management.
* Software verification and validation.
**Reputation / proof points**
* Over 30 years of experience in the field.
* Assists companies in the USA, Europe, Asia, and Latin America.
Additional information
Sigma Scientific Services LLC provides comprehensive support for medical device companies navigating complex regulatory landscapes. Their services extend beyond initial product approval to include ongoing compliance engineering and advice on manufacturing operations. They emphasize a cost-effective approach, helping clients optimize their regulatory strategy from development through to market entry. The team is equipped to handle a range of engineering disciplines, ensuring a holistic approach to product compliance and validation.
Key Highlights
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Over 30 years of experience in scientific and engineering projects requiring biomedical, software, electronics, and mechanical engineering expertise.
Source
“With more than 30 years of experience in the field we can assist you in your scientific and engineering projects that require biomedical, software, electronics and mechanical engineering expertise”
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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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Services include consulting, product testing, quality management systems, USA agent representative, and establishment registration.
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 advice on regulatory affairs, compliance engineering, and manufacturing operations.
Source
“We provide advise not only in regulatory affairs but also in compliance engineering and manufacturing operations.”
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Experience includes feasibility studies, rapid prototyping, product development, product 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 and implementation of quality procedures.”
Buyer Snapshot
Best for
- Companies seeking FDA registration and listing services.
- Businesses needing assistance with product development and regulatory approval.
- Manufacturers requiring support for quality management systems.
How engagement typically works
- Consultative approach to regulatory strategy.
- Leveraging scientific and engineering resources.
- Focus on cost-effectiveness and efficiency.
Typical deliverables
- Regulatory strategy reports.
- Product testing and validation reports.
- FDA registration and listing support.
- Quality management system documentation.
- USA agent representation.
Good to know
- Best when requiring expertise in medical device regulations.
- Best when seeking to streamline product development and approval.
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
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