Medical Devices

Medical Device Registration USA, Latinamerica & Europe

FDA 510(k) approval process \ Analysis

Identification of device class, product code and regulation number
Identification of predicate device
Identification of test standards
Identification of 510k test requirements
Preparation of 510Ks, pre-IDEs, IDEs, and PMAs
Document redaction
Design and preparation of packaging, labels, product inserts and instructions for use
Answering regulatory questions
Reviewing and editing 510(k)

Applications on FDA and/or Health Authorities in Latin America (Mexico, Colombia, Brasil, Peru, Panama, Ecuador)

CE Mark Certification for Medical Devices & IVD

To sell medical devices in the European Union (EU), you must obtain or apply CE Marking for your product. CE Marking indicates that your medical device complies with the applicable EU regulations and enables the commercialization of your products in 32 European countries.

As a legal medical device manufacturer, you are responsible for maintaining regulatory compliance and securing CE marking for your product, regardless of whether you outsource any or all components of your manufacturing operation.

  • Medical Devices Directive (93/42/EEC), In Vitro Diagnostic Devices Directive (98/79/EC), or Active Implantable Medical Devices Directive (90/385/EEC).
  • Medical Device Regulation (MDR 2017/745) comes into force in May 2021

Medical Device Registration

GAP Analysis EU MDR Product Approval Requirements

Technical File Design Dossier

(UDI) Unique Device Identification

Notified Body and EU Competent Authorities Contact

APPLICANTS

Foreign manufacturers / exporters or U.S. representatives of foreign manufactures / exporters introducing a device to the U.S. market also requiere FDA 510(k) submission.

Domestic manufacturers introducing a device to the U.S. market.

Specification developers introducing a device to the U.S. market.

Applicants Repackers or relabelers who make labeling changes or whose operations significantly affect the device.

SERVICES

01.

Applicants

FDA Establishment
Registration

02.

Applicants

Assistance in Device Listing with FDA

03.

Applicants

U.S. Agent & UDI Submission

04.

Applicants

Medical Device Registration 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

Regulatory Affairs Training

Webinars and short courses. Courses and Webinars can be provided to private parties or individuals under a different pricing structure.

Product Safety and Performance

This series of courses discuss specifics about various safety and performance tests including software, electrical and mechanical tests.

Quality Management Systems

Our team of experts provide training to help you implement and maintain a Quality Management Systems.

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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