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Medicom

CASE STUDIES

Duration    

6 months

 

Client    

Our client a major international Medical Device Manufacturer, headquartered in NJ, USA.

 

Description    

Their strategy was to establish a new manufacturing facility in Ireland to manufacture a neurological surgical device which had been purchased from the original product designer and manufacturer also located in the USA. The Irish facility was to be ready within 6 months to receive, manufacture and distribute the new product to the EU and USA markets.

The project contained many risks and the complexity required tight management and control. Project management expertise was an essential pre-requisite coupled with expert knowledge and understanding of the medical device GMP requirements for both electromechanical and sterile disposable products.

 

Duration

12 months

Client

Our client a major international Medical Device Manufacturer, headquartered in NJ, USA, with manufacturing locations in Belarus and Slovakia.

Description

The project was to transfer sterilization processing of existing products manufactured in Slovakia and Belarus to a new Contract Sterilization Facility located in Belarus. This is the preferred option to the existing sterilization supplier in Slovakia (an EU Country) - this means most manufacture and all sterilization will all take place within the Russian Federation providing optimal flexibility for distribution of the product portfolio within the Russian Federation. This transfer necessitated full validation of 100% EO Sterilizers in accordance with ISO 11135 requirements. The project contained many risks and the complexity required tight management and control across several locations.

Duration   

9 months (US & Switzerland)

 

Client   

Our client a major international Medical Device Manufacturer, headquartered in NJ, USA, with manufacturing locations globally.

 

Description   

The project was to coordinate quality system remediation across multiple facilities following a Consent Decree agreement with FDA.