We transform one good idea into a rigorously conforming commercial product

Our goal is to ensure that your medical products and services meet the highest quality and safety standards, and that you achieve your business objectives

Keys to success

This are our main focus in each project to achieve the best results

Regulatory Affairs

We are responsible for ensuring medical device´s developers, manufacturers, importers and marketers compliance with applicable global legislative and regulatory requirements.

Quality Assurance

Focused on providing confidence that quality requirements will be fulfilled. We perform Audits, CAPAs management, Risk Management Plans and GAP analisys and we implement the solutions.

International Medical Device Consultancy

Ready to develop for you an international regulatory strategy in order to abord multiple markets researching the regulatory requirements for each country.

Design And Development Documents

The help you need to prepare a Test Plan, Risk Analysis File, Software Validation´s Documents, Design History Record and PCCPs.

How we work

Meet our workflow

Fill the form to contact Us

We Will get in touch with you to schedule a meeting.

Send Technical Requirements

We Will propose you a Regulatory Affairs program.

Agreement and budgets

Develop the documents, prepare the files, pay fees.

Submit the information to FDA

After a submission process you receive the approval.

our partners

Some of the regulatory institutions we work with

COFEPRIS

Federal Commission for Protection against Health Risks

ANMAT

National Administration of Drugs, Food and Medical Devices

FDA

U.S. Food and Drug Administration

INVIMA

National Institute for Food and Drug Surveillance

ANVISA

Brazil National Health Surveillance Agency

About Us

We are a specialized team providing consulting services to companies engaged in the design, development, manufacturing, import, and marketing of technology-based products. Since our establishment, we have excelled as experts in regulatory matters at both national and international levels, establishing ourselves as leaders in quality systems. With over 20 years of experience, we understand that the world is advancing towards new technologies, environmental sustainability, and the practical application of science in everyday life. That's why we've created "TRISKEL TECH," our Science and Technology Center, an original project with the primary goal of teaching ROBOTICS, PROGRAMMING, and DESIGN, preparing future generations through the STEAM methodology, recognized for its global success

Our Mission

Enable the successful development of “end to end” projects.

We aim to play a role in the growth of companies and institutions, supporting them in the successful realization of their projects with a comprehensive range of products and services that address specific challenges. Our goal is to empower every technology-based product and service company to transform "that great idea" into a "marketable product." We offer specialized business services in Highly Regulated Processes, associated with various technologies and innovations, including Medical Products, Software, Pharmaceuticals, Medications, Food, Functional Safety Systems, and Robotics.