Who we are
SechMed’s team is composed of highly experienced medical device professionals with decades of combined expertise in medical technology. We have a track record of successfully developing devices across a range of areas which adhere to global standards, including ISO 13485, IEC 60601, ISO 14971, and FDA regulations. Our collective strengths span creativity and concept generation, human factors, mechanical design engineering, product regulatory expertise, and manufacturing knowledge. Having worked seamlessly together for over a decade, our team is tried, tested, and trusted.
We are a versatile design and development team, able to provide specialist input at key stages or manage a full project under comprehensive design controls.
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Shane MacNally
CEO
Shane is a highly-experienced and innovative leader with over 25 years in advanced manufacturing, R&D, and medical device development. Proven success in regulatory compliance, product development, clinical validation, and intellectual property generation. Adept at cross-functional leadership and global collaboration with clinicians and regulatory bodies.
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Ronan McManus
Director of Product Realisation
Ronan has 30 years experience in the management of medical device development projects, from initial design through to market approval & release. Highly-experienced in Risk Management processes to ISO 14971, Biological Evaluation of materials to ISO 10993, and compliance with the systems requirements of ISO 13485 and FDA QSR & CGMP.
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Ed Hyland
Director of QA & RA
Ed has over 25 years of experience in medical devices, including 20 years in senior leadership roles, strong track record in RA, QA, and manufacturing across global markets. Brings a solutions-focused, collaborative approach to complex regulatory and quality challenges, having led teams and projects through EU MDR, FDA QSR, ISO 13485, and multiple global compliance frameworks. In 2024 completed a Master of Science in Medical Technology RA at ATU/University of Galway, graduating first in class.
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Stephen Williams
Director of Design Engineering
A Medical Device Design Engineer with 13+ years of experience in creative and technical development of medical technologies. Proven expertise in ISO 13485 design control from concept development and advanced design to prototyping and usability engineering. Strong background in driving intellectual property generation. Holds a First-Class Honours Degree in Mechanical Engineering and a Master’s in Medical Device Design.
Contact us
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