Gary Brogan Email & Phone Number

County Galway, Ireland

Irvine, California, US

Bochum, NRW, DE

Bochum, NRW, DE

Established the Quality Department in a new facility in Galway. This included the implementation and successful ISO13485 registration. Managed all aspects of US market clearance for two 510(k) Non-Touch Infra-red Thermometers.

Member of the Senior Management team of two sister companies with direct ownership of the regulatory function for both. Developed the EU and US regulatory strategies for all the products, ranging from bioresorbable scaffolds to foams used for peripheral embolization. Novel regulatory strategies employed included denovo 510k, Humanitarian Device Exemptions.

Quality, Regulatory and Clinical responsibility to bring a nitinol coronary stent through the CE Marking process, including the completion of a pre-market clinical trial. Subsequent market release activities involved country registrations, reimbursement submissions, product training and proctoring and the management of both post market clinical trials and.

Marlborough, MA, US

Contract work to re validate a number of product lines to revised company requirements, stemming from an FDA warning letter.

Design assurance responsibility to ensure that two concept stent coating machines were subjected to full Design Control as per ISO13485.

Marlborough, MA, US

The quality lead for the transfer of 8 Wallstent product lines from the US to the Galway plant. Tasks involved all aspects from due diligence to first lot to stock from Galway Plant.

Msc, Bioengineering

Bsc, Quality Management