Call Us Today: + 34 91 417 04 57

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Medical Device and Pharmaceutical Consulting

to support the fulfillment of MDR, UDI, DHF & Tech-File requirements

Are you ready for the EU MDR?

Contact Us Today for a complimentary EU MDR Compliance Check

MDR Readiness Check Online Form

EU MDR countdown

Days
Hours
Minutes
Seconds

The MDR impact for your company

find out the stage that covers your needs

Pre-market requierements

Stricter standards Clinical evaluation & risk management

Clinical justification for device equivalence

Labels

UDI,dangerous substances, Symbols & ISO 15223-1 rev.

Definition & classification

Post-market requirements

Revised rules for designation & classification often meaning devices fall under higher risk classes

Higher traceability

UDIs & implant cards EUDAMED registration

48h countdown for severe malfunctions reports

Manufacturer

for reprocessing Single Use Devices

Harmonized

EU-wide data collection of medical devices in patients

Gap analysis

I. Technical documentation

II. UDI system

III. Clinical evaluations and investigations

IV. Quality SOPs Design to pass QMS

I. Creation of technical documentation

II. UDI data, labeling and direct marking

III. PMS / PSUR

IV. Clinical & SSCP Summary of Safety & Clinical Performance

Implementation

I. ISO 13485:2016 & MDSAP compliance

II. MDR audit and deficiency support

III. FDA audit and deficiency support

Certification

1

2

3

Full coverage services

from gap assessment to execution

MDR compliance check

online form


PROJECTS

YEARS

CLIENTS

Your Partner for MedTech Companies

Thanks to our product development capabilities, we know how to bring technology from the lab and put it on paper. We accompany medical device companies from MVP to the market.

+100

+5,000

+15

How we work

Our mission is to support our clients to develop and market innovative products.To accomplish that, we offer a complete 360-degree service. From concept generation and innovation strategy through to product development and market launch, Inspiralia helps companies with their global product launch

Have a loook to our Health and Wellbeing projects

Around the world

We are specialists in New Product Development

Get in touch

| +34 914 170 457 |

MIAMI

1951 NW 7th Avenue, Miami, FL 33136 - USA

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SWITZERLAND

Cham, Switzerland

Calle Manuel Tovar 49, 28034 Madrid, Spain

MADRID

4 Oakington Business Park, Dry Drayton Rd.,Oakington, Cambridge, CB24 3DQ – UK

CAMBRIDGE

VIENNA

Stallburggasse 4/2/8,A-1010 Wien, Austria

Contact Us Today for a complimentary EU MDR Compliance Check

Are you ready for the EU MDR?

MDR Readiness Check Online Form