Medical Devices
FDA Medical Device Registration & Regulatory Compliance
FDA 510(k) Clearance — End-to-End Support
We guide you through every step of the 510(k) process to bring your medical device to the U.S. market efficiently and compliantly.
- Identification of device class, product code, and regulation number
- Identification of the predicate device
- Identification of test standards and 510(k) requirements
- Preparation of 510(k)s, pre-IDEs, IDEs, and PMAs
- Document redaction and technical writing
- Design and preparation of packaging, labels, and instructions for use
- Answering FDA regulatory questions
- Reviewing and editing 510(k) submissions
Also supporting regulatory submissions in Latin America (Argentina, Brazil, Ecuador, Peru)
Also supporting regulatory submissions in Latin America
(Brazil, Argentina, Peru, and more)
Global Market Access for Medical Devices
One Partner. FDA & Beyond.
Whether you need FDA clearance, U.S. Agent representation, or regulatory approval in Latin America — we centralize all your submissions under one team.
No need to coordinate multiple consultants across different countries. We manage your regulatory strategy from a single point of contact, saving you time and reducing costs.
We support registrations in:
- 🇺🇸 United States (FDA)
- 🇧🇷 Brazil (ANVISA)
- 🇦🇷 Argentina (ANMAT)
APPLICANTS
SERVICES
Applicants
FDA Establishment Registration
Applicants
Device Listing with FDA
Applicants
U.S. Agent & UDI Submission
Applicants
FDA Registration Annual Renewal
TESTING
Acoustical tests for diagnostic ultrasound systems and transducers
The accurate quantitative determination of the spatial and temporal characteristics of ultrasonic fields in diagnostic ultrasound devices is important for safety reasons. The precise determination of acoustic output and other field quantities, and how they vary in time and space, allows manufacturers of diagnostic ultrasound equipment to evaluate if the diagnostic ultrasound system is within the safety margins or FDA preamendment values.
Software Verification and Validation - Compliance
Medical products need to be safe and effective. Thus, the product development process needs to take into account safety regulations during design, development and manufacturing to ensure patient and operator safety as well as to ensure not interference with the environment. Lack of knowledge and experience with safety regulations causes large and costly delays in finishing a compliant product and obtaining its approval thereof.
IEC 60601-1 Electrical Safety Testing
Medical Device Training Academy
Training is provided at various levels, depending on the knowledge and expertise of the participants in each course. Our instructors have years of practical experience in every subject taught, and are experienced in training and education. Training is provided Online through 1-hour Webinars, 2-4 hour short courses and 6-12 hour courses.
Courses and training can be customized as per your specific requirements in terms of topics and duration. Courses can be provided in Spanish as well.
Characteristics
- Online – synchronous and offline
- Live instructor interaction
- Learn at your own pace
- Short training for executives and managers
- Short term courses for employees
- High ROI
- Meets ISO 13485 (6.2) Human resource requirements
We understand the value of knowledge, training and education and how they have the potential to impact lives, businesses and communities. Thus, we have created the Medical Device Training Institute providing basic, intermediate and advanced level training in key areas relevant to the medical device industry. Our mission is to provide continued education and practical knowledge so engineers and administrators stay in compliance with regulations and medical devices are developed, manufactured and distributed in a safe and effective manner.
Courses and training can be customized as per your specific requirements in terms of topics and duration. Courses can be provided in Spanish as well.
Characteristics
- Online – synchronous and offline
- Live instructor interaction
- Learn at your own pace
- Short training for executives and managers
- Short term courses for employees
- High ROI
- Meets ISO 13485 (6.2) Human resource requirements
We understand the value of knowledge, training and education and how they have the potential to impact lives, businesses and communities. Thus, we have created the Medical Device Training Institute providing basic, intermediate and advanced level training in key areas relevant to the medical device industry. Our mission is to provide continued education and practical knowledge so engineers and administrators stay in compliance with regulations and medical devices are developed, manufactured and distributed in a safe and effective manner.
Før more information
Our goal is to facilitate the creation of a positive business environment supported by an adequate, modern and efficient team is key to stimulating business expansion.
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