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.
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
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
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
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
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.