Sigma
Core Values

We know it is not easy to select the appropriate regulatory consulting firm. Some have more recognition than others, and that usually comes at a higher cost. There exist numerous options at very different cost structures, usually with additional hourly costs per additional engagement time. To help you take an educated decision, we present below our core values. We look forward to serving you!

Commitment to success
In Sigma we are fully committed to the success of our clients. This implies going the extra mile, working with your team addressing requirements and providing timely responses to the FDA, making ourselves available even during weekends for discussions and expediting work.

Communication
We know communication is important to the success of any project. That is why Sigma is constantly available during the execution of each project. Our goal is to provide fast and effective communications and responses to our clients within a 24 hour window.

Trust
We value Trust and believe it is important in the decision making process of every client. We have been providing regulatory consulting and testing services to our clients since 2005. We are an ISO accredited company and have successfully completed regulatory and testing projects for small and large clients in USA, Europe, Asia and Latin America.

Knowledge and experience
Sigma Biomedical'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.

Cost
In this industry there are many cost options and we are in the middle of available options. Our pricing structure makes sure you get the most value out of your investment with no surprises.

Quality
We believe in quality and excellence, and we know this requires effort, expertise and commitment. We strive to provide our clients with a great service that meet and exceed expectations.

Timing
We strive to provide fast, accurate and effective responses to our clients and to the FDA in every project. We understand the value of time and opportunities, thus we strive to stay on top of our projects so they can be completed on time or sooner if possible.

Customer satisfaction
Our mission is customer satisfaction, and that is why we aim to excel in timing, project cost, customer service and effective results so our clients are satisfied with our involvement.