Regulatory Affairs for Medical Devices, IVD and Biocide products Consultancy Firm

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Providing specialized support to your company in Spain, Portugal and Latin America

Regulatory Affairs Management

Consultancy

Trading MD

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We are a consultancy specialized in regulatory affairs for companies and professionals that provides technical advisory services in the regulation of medical devices, IVD and biocide products in Spain, Portugal and Latin America.

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Helpful blog

What is ISO 13485?

ISO 13485 is an international standard that specifies the requirements for a quality management system (QMS) applicable to medical devices.

What is a Technical Manager for medical devices?

A Medical Device Technical Manager is a professional appointed by a medical device manufacturer or distributor.

How is the current MDR for medical devices different from the previous MDD for medical devices?

Here you will find a summary of the differences between the MDD and the current MDR

How to market medical devices and IVDs products in Spain and Portugal

In this Guide we teach you all the necessary steps established by the Health authorities in Spain and Portugal to market DM.