About Us

Who We Are

Why You Should Choose Us

Sigma Biomedical provides complete regulatory consulting services for US FDA, Mexico COFEPRIS, Argentina ANMAT, Brazil ANVISA, and Colombia INVIMA product approval submissions, as well as support for other medical regulatory affair needs, such as product safety, engineering compliance, and Quality Management Systems implementation. Sigma’s regulatory, engineering, and scientific team can efficiently help you achieve product approvals so you can reach US and international markets sooner than ever.

Sigma goes beyond traditional regulatory consulting giving you the extra advantage of a product engineering team that also assists in medical product development and testing. Sigma strives to provide customers with cost effective services, solutions and approval strategies ensuring that their products will receive approval without delays, thus maximizing return on investment. Our team of experienced engineers who understand the product development process will work with your team to bring all these promises to reality.

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1500 +

Patient/Year

250 +

Satisfied Patients

315 +

Health Sections

180 +

Kinds of Research

250 +

Award Winning

Working Process

How We Work?

Our expert are always provide best health care service. Why Sigma Biomedical service is best for the heart treatments all types of patients like children's, elders etc...
Product Development

Product Development

Medical Devices
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
Product Testing

Product Testing

Engineering compliance
Medical device industry is highly regulated, and products need to be shown safe, effective and in compliance with regulations. Sigma assists companies in the testing and validation of products.
Quality Management

Quality Management

Quality Management
Products need to be developed and manufactured under good manufacturing practices. Sigma Biomedical assists companies in the implementation and compliance of their quality management systems
Regulatory Affairs

Regulatory Affairs

Regulatory Affairs
FDA and International Regulations are complex and continuously evolving. Sigma Biomedical expertise takes the headache away and helps you stay in compliance with regulations

About us

Sigma Scientific Services (Sigma Biomedical) is a medical device safety and performance testing laboratory. Sigma is accredited by A2LA under the ISO/IEC 17025 quality management standard and is accredited by the FDA under the ASCA program as a medical device safety testing laboratory. Our knowledge and expertise includes diagnostic ultrasound systems and transducers, materials such as ultrasound gels and probe covers, endoscopes, physiotherapy systems and in general medical devices. Our services include acoustic, electrical, optics, thermal, software and material property testing under various recognized test standards, and custom developed test protocols.

Sigma Scientific Services is an A2LA accredited laboratory under the ISO/IEC 17025 standard for acoustic test methods. Click Here for our accreditation certificate.

Our core values

Communication

We know communication is important to the success of any project. Our goal is to provide fast and effective communications and responses to our clients.

Knowledge and experience

Sigma Scientific’s professional and scientific team have more than 100
years of combined experience in various aspects of medical devices,
regulatory affairs and quality management systems. In this highly regulated
environment, ability to understand, apply and stay in compliance with
regulations is crucial for the success of every project.

Quality

We believe in quality and excellence. We strive to provide a great service that meet and exceed expectations.

Timing

We understand the value of time and opportunities, thus we strive to provide accurate time estimates of project completion

Customer satisfaction

Our mission is customer satisfaction, and that is why we aim to excel in timing, project cost, customer service and effective results

870+

Satisfied Patients

What We Offer

Our expertise

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. You can leverage Sigma Biomedical scientific, engineering, quality, compliance engineering and regulatory resources to make the process more efficient and cost effective.

Benefits

We provide advise not only in regulatory affairs but also in compliance engineering and manufacturing operations. Our experience includes feasibility studies, rapid prototyping, product development, product testing, risk management, software verification and validation and implementation of quality procedures.

About Us