About
About Sigma
igma Scientific Services 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.
1500 +
Patient/Year
250 +
Satisfied Patients
350 +
Health Sections
180 +
Kinds of Research
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.
01
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.
02
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.
03
Quality
We believe in quality and excellence. We strive to provide a great
service that meet and exceed expectations.
04
Timing
We understand the value of time and opportunities, thus we strive to
provide accurate time estimates of project completion
Frequently Asked Have Any Question?
01. 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
02. 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.
03. 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
