Clinical Engineering

Clinical Engineering

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Premarket Services 

Verification and validation of medical devices.

Testing is a critical step in the transformation process of innovative design in a reliable and marketable product. Thus it has been created solutions for technology assessment. Tests to help you demonstrate your device is compliant with the regulations anywhere in the world. 

 

Advice and support in certification of medical devices

This brand is in charge of researching and advising on quality management processes that indicate compliance with required international standards such as ISO 13485, ensuring that its products are manufactured under a strong quality control and risk management policy.

 

 Advice on certification processes for manufacturers and laboratories.

Created to study and advice on developing a quality management system for new test laboratories and medical device developers that fit the best to ensure that all medical device processes are taken into account.

 

Design of evaluation protocols for medical devices

The evaluation process is carried out not only to verify if the product meets minimum requirements but to propose and establish footholds for the manufacturer be prepared to build a quality device.

 

 

 

 

Postmarket Services 

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Support in hospital infrastructure development

 

Our center provides advice and support in processes of design, construction and renovation of hospital infrastructure that not only is leveled to technical standards, but also allows to set internal quality processes according to criteria of certification and accreditation.

 

 

Biomedical technology Management services 

 

In our center we care to use quality standards that the current market demands. We have experience to advise throughout the entire cycle of technology management at your institution, from the estimation of technological needs, the evaluation process for the acquisition of technology, purchasing and tender processes, maintenance, prolongation and verification of technology services. 

 

 

 

Biomedical maintenance training

 

We contribute to quality assurance and improvement in the productivity of companies through training services, consulting and implementation of medical monitoring equipment, according to the specific needs of your institution, aimed at professional and technical staff of clinical engineering department or biomedical maintenance.

 

Habilitation, certification and accreditation processes auditing

To certify the quality of internal processes in a company is an issue of particular concern because their length and complexity can make a difference in attention to its users, it is why our this project centers to investigate best practices and advise health companies on developing models and processes that have been recognized in accordance with national regulations and standards of quality.