Skip to content

Our facilities.

Our facilities include a 30,000 square-feet dedicated healthcare manufacturing plant located at our global headquarters Castlepollard, Ireland. Our cleanroom environments meet ISO Class 8 standards to ensure the production of sterile medical components.

Our approach to quality and regulatory affairs.

Mergon Healthcare upholds strict compliance with relevant regulatory standard ISO 13485, to ensure the manufactured blow moulded, injection moulded and medical device components meet required quality and safety standards.

Our quality laboratory facilities support critical to quality dimensional testing for batch release. We use certified external partners for drop testing, ageing, DSC and CT scanning. We have a proven track record of successfully navigating regulatory approvals for medical devices including MDR technical file preparation.

Our Partners.

Mergon has an extensive international network of expert partners whom we work closely with to optimise outcomes for our customers.

Healthcare Product Lifecycle.

Mergon Healthcare has high maturity manufacturing capabilities through the full product lifecycle. Mergon has a tenured team of Healthcare manufacturing professionals with deep technical competency in Healthcare programme management , product design and industrialisation

Don’t see what you’re looking for?

We are always innovating and trialling new solutions for the healthcare sector.

Contact us today about solutions to suit your business.

Contact.

Looking for an email or location address? Click here.