ISO 14971 Risk Management for Medical Devices Certification

ISO Training Provider

Irish Quality Centre (IQC)

Cork

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.

ISO Training Provider

Comply Guru

Limerick

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.

ISO Consultant

Rook Quality Systems

Dunwoody

Since 2012, Rook has been dedicated to helping medical device companies develop and maintain effective and efficient quality systems, and to providing them with the right resources and expert insight. Our mission is to enable our clients to implement compliant Quality Management Systems (QMS) to ensure that they can efficiently produce effective and reliable medical devices. We build these QMSs so that our clients can get their devices to market faster than standard methods, and once on the market, manage these systems to continue producing quality devices.The RookQS team leverages its extensive experience and expertise in quality and regulatory strategies for emerging and established medical device companies to help our clients get their devices to market significantly faster than standard methods.Our consultants provide clients with the necessary tools to comply with regulations in both domestic and international markets, with specialists in FDA regulations, MDSAP audits, ISO 13485:2016 compliance, and MDR conformity. Our diverse team works with a wide range of devices (including class I-III devices, SaMD, and IVDs).RookQS? team of experienced, certified Quality Engineers features 13 certified quality auditors (CQAs) for a variety of regulations, including FDA 21 CFR 820, ISO 13485:2016, MDSAP, and CE Mark under MDR.