We share our clients’ commitment to progress in health protection.

Life Science is our business

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Medical Device Software (MDSW) III – Validation

The design and development of the MDSW includes the verification and validation stage that is critical for its certification. The IEC 62304 guides you thought the […]

medical-devices2

Medical Device Software (MDSW) II – Classification

Once you know that the software with a medical purpose is considered a MDSW and it is covered by the Medical Device Regulations, you need to […]

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Medical Device Software (MDSW) I – Definition

Although new Medical Device Regulation (EU) 2017/745 – MDR is postponed for one year until the 26th May 2021, manufacturers are working to provide or update […]

LIFE SCIENCES IS OUR BUSINESS

We provide consultancy services to the Health and Life Sciences Industry since 1997.

INSPIRED BY A COMMON GOAL

We share our clients’ commitment to excellence and innovation to advance on public health protection.

WE ARE A GLOBAL COMPANY

Our clients count on us for all their projects and activities worldwide. We operate globally from our Headquarters in Barcelona and Shanghai.

COMPREHENSIVE SERVICES WITH ADDED VALUE

We offer our extensive experience and highly qualified consultants and engineers to provide top-class services on Validation, GXP Compliance and Quality.

TDV News

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New IVD plant

Company profile: An International In Vitro Diagnostic Medical Device Company in Spain move its current manufacturing site to a new location, including both offices as well […]

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Qualification activities for cosmetic industry for USA market

Project scope: A cosmetic company wants to commercialize a product manufactured in Spain to USA market which is considered as an OTC by FDA. The scope […]

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EUGMP Annex 1: Requirements on Sterile products

EUGMP Requirements on Sterile products … What’s next?   EUGMP Annex 1 was first published in 1971 and the current version came into operation on 2009 […]

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    Octavi Colomina