ISO 13485 Providers
in Ireland
Find verified ISO 13485 Medical Devices Quality Management consultants, certification bodies, and training providers in Ireland. Compare profiles, read reviews, and get free quotes — no obligation.
Comply Guru was launched in 2019 as an Approved Training Provider specializing in new innovative learning methodologies to offer globally recognized qualifications that are available in an online, face-to-face or blended format for ISO Standards, Auditing and Medical Device Regulations. Our Founder, Eoin P. Kelly, identified a major gap in the market for learning solutions that were more dynamic, flexible, and convenient for the modern workforce that juggles busy professional and/or personal lives. We are proud to say that our training has been delivered globally and is trusted by both Leading Organizations in Industry & Notified Bodies. Comply Guru are the first of our kind. We have set a precedent for innovation by becoming the first organization to specialize in both online and blended learning solutions. Our pioneering approach has enabled us to develop exceptionally effective methodologies that provide more accessible and flexible avenues for obtaining premium certifications. We take great pride in being the first organization to attain several groundbreaking accreditations in online and blended learning for Medical Device QA/RA, ISO Standards and Internal & Lead Auditor Courses.
Irish Quality Centre (IQC) has been in business since 1997 and is one of Ireland?s leading providers of training, consultancy and auditing in Quality Management Systems, Environment, Health and Safety and Continuous Improvement across all industries. ? The Irish Quality Centre has been bestowed with the esteemed title of Business All-Star Auditor Training Company of the Year 2024 by the renowned All-Ireland Business Foundation, a testament to their unwavering commitment to excellence in professional training services.? Our internationally accredited IRCA and Exemplar Global approved Auditor Training courses include Internal Auditor, Lead Auditor along with auditor transition for ISO 9001, ISO 13485, ISO 45001, ISO 17025, ISO 14001 and Pharma/Biopharma.? For the Medical Device industry in addition to Auditor training we offer ISO 13485, Medical Device Regulations (MDR), Medical Device Single Audit Program (MDSAP) and ISO 14971 Medical Device Risk Management training.? We also assist organisations by integrating standards such as ISO 13485, ISO 9001, Good Manufacturing Practice (GMP), ISO 14001 and ISO 45001 with their business strategies. We take great care in selecting highly competent, technical people who have the necessary professionalism and interpersonal skills to be able to collaborate well with our clients.
QMA offer ongoing consultancy, systems implementation and certification services, providing support for a range of standards, including ISO9001, ISO14001, ISO45001, ISO13485, ISO27001 and ISO50001, we can help any organisation, in any sector, implement and run their ISO Management Systems from our Dublin Limerick Cork and Belfast locations. We also offer a representative service to organisations located outside of the State of Ireland. QMA has helped implement system audits for many types of organisations, both large and small, across a wide range of industries since 2011 throughout Ireland, we work closely with all of our Partners as detailed below. ?We offer straight forward and cost effective consultancy and certification services which are designed to take the hassle, and much of the unnecessary cost, out of the certification process for our customers.
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Consultants, certification bodies, and training providers based in or serving Ireland
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About iso 13485 providers in ireland.
CertBetter lists verified ISO 13485 Medical Devices Quality Management providers based in or serving Ireland. Filter by service type (consultant, certification body, training), compare profiles and verified reviews, and submit a single free quote request to hear from multiple specialists simultaneously.
Not necessarily. Many ISO 13485 Medical Devices Quality Management consultants work remotely with clients worldwide and can deliver gap analysis, documentation, and training entirely online. However, a locally based consultant in Ireland may have an advantage for on-site work, regulatory familiarity, and surveillance audit support.
Total ISO 13485 Medical Devices Quality Management certification costs in Ireland typically range from $5,000 for a micro business to $60,000+ for a complex medium-sized organisation. This covers consultant fees (gap analysis, implementation, documentation, training) plus certification body audit fees (Stage 1 and Stage 2). Getting multiple quotes through CertBetter is the fastest way to benchmark pricing.
Most Ireland businesses complete first-time ISO 13485 Medical Devices Quality Management certification within 4–12 months. Organisations with existing documented processes and a dedicated internal lead move significantly faster — sometimes within 3 months. A gap analysis at the start is the best way to set a realistic and accurate timeline.
A ISO 13485 Medical Devices Quality Management consultant helps you prepare — conducting gap analysis, building documentation, training staff, and getting audit-ready. A certification body (CB) is an accredited organisation that independently audits your management system and issues the certificate. They are separate roles, and you typically work with both. CertBetter lists both types in Ireland.
Technically yes, but it is significantly harder and slower without expert guidance — especially for first-time certification. Most Ireland businesses that attempt self-certification take longer, face more audit non-conformances, and end up spending more overall. A consultant typically pays for themselves in time savings and reduced re-audit risk.