Medical Device Consulting
The result of ideas
Specialised advice, management, documentation, certification, monitoring and technical management service for medical devices.
MEDICAL DEVICE
Specialised advice, management, documentation, certification, monitoring and technical management service for medical devices.
RULES AND REGULATIONS
Directive 93/42/EEC and EU Regulation 2017/745 are the main reference standards in the regulation of medical devices.
MEDICAL DEVICE SECTOR
Efficient quality system: “it is not enough to comply with obligations, but to do it in the simplest and most functional way for your company”.
About us
What is a medical device?
A medical device is any instrument, device, equipment, computer program, material or any other article used for the diagnosis, prevention, control, treatment or relief of a disease, injury or deficiency.
Also that which is used for the research, substitution or modification of anatomy or a physiological process and also for the regulation of conception.
What do we offer?
A quality management system, typically based on UNE-EN ISO 13485, will be the key tool to achieve compliance with regulatory and customer requirements.
Consulting is a professional service based on experience and specialization.
At PS Consulting we offer a consulting service in special installations and medical devices, with a high level of technical knowledge and a clear focus on efficiency: achieving the maximum, with sufficient resources.
At PS Consulting we have extensive experience in product consulting and technological solutions in the healthcare environment.
We advise, and prepare the required documentation, in relation to the regulatory compliance system for medical devices.
Future
THE FUNDING THE GAP STUDY PREDICTS THAT PUBLIC HEALTH EXPENDITURE IN SPAIN IN 2025 COULD DOUBLE THAT RECORDED IN 2015, REACHING ALMOST 115,000 MILLION.
Fernando Atienza
Technical Director of PS Consulting, he has more than 10 years of experience in multi-sector consulting, always in the healthcare market.
Our philosophy
We are clear about what the goal is: efficiency. By achieving your goal, making it ours, we achieve satisfaction and, with it, efficiency.
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