EU MDR SIMPLIFIED
Overview on MDR and its impact on medical device, pharmaceutical manufacturers and developers. We will be discussing successfully proven and unique approach to re-certification.
EU MDR SIMPLIFIED
Overview on MDR and its impact on medical device, pharmaceutical manufacturers and developers. We will be discussing successfully proven and unique approach to re-certification.
EU MDR SIMPLIFIED
Overview on MDR and its impact on medical device, pharmaceutical manufacturers and developers. We will be discussing successfully proven and unique approach to re-certification.
EU MDR SIMPLIFIED
EU MDR SIMPLIFIED
WHAT WE DO
MEC is a comprehensive solution provider with a full suite of services from consulting and contracting to training and cost savings initiatives. Our goal is to achieve positive change for our clients through tools and methodologies that provide immediate impact, sustainable results, and knowledge transfer that continue to bear dividends over time.
Coupling these tools and methodologies with our passion for mentoring and belief in true issue ownership, enables us to blend seamlessly with our client’s operations and drive positive cultural change from within.
WHO WE ARE
Founded by seasoned industry professionals, MEC was created to address the market’s unmet needs. Armed with their knowledge of best-in-class systems, the founders have successfully developed a company offering deep insight and a proven ability to seamlessly partner with clients during times of expansion or times of challenge. We have become the go-to resource throughout industry, providing comprehensive and successful solutions from start-up to major multinational companies.
MEET THE TEAM
Christopher Gustine
Managing Partner
Christopher leads the business development division of MEC. He has over 10 years of experience in the medical device and pharmaceutical manufacturing field. Responsible for Medical Engineering Consultants' daily operations and business growth, he partners with clients as their
go-to resource for their consulting needs. Christopher possesses the know-how to simultaneously manage multiple projects while leading quality improvement initiatives with excellence.
David Campo
Co-Founder and Principal
David has over 15 years of experience in Quality systems, Regulatory Affairs, R&D, and Manufacturing Operations. This robust background enabled David to excel in multiple leadership roles in all the major Medical Device industry functional areas. David is not only a well-rounded engineer, but also a savvy manager who understands the dynamic connections between all the functional areas, to truly achieve operational excellence in every project. David holds a Master’s Degrees in Bio-medical Engineering and Engineering Management and a proven record of success.
Fergal McAndrew
Co-Founder and Principal
Fergal leads the operations, engineering and OPEX divisions of MEC. He started his life sciences career at Boston Scientific in Ireland, holding positions in both R&D and process development where he was at the forefront of several critical project launches. Upon moving to the United States, Fergal moved into project, engineering and operations management while also driving key quality initiatives and QMS improvements. This product life cycle experience coupled with certifications as a six sigma black belt, project manager and biomedical auditor has allowed him to excel in the consulting arena becoming a go-to resource for senior leadership to help properly diagnose issues, formulate concise action plans and drive flawless execution.