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The Kelmac Group® has developed a unique tradition of creating learning services that shape the future of conformity and compliance learning solutions for Executive Management, Practitioners and Auditors.

Where others train followers, we train leaders™

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ISO 13485 Training Courses | ISO 13485 Certification

There is probably no other industry where the importance of product conformity is as crucial as that in the design and manufacture of medical devices. Standards in any industry are an important way both to safeguard product conformity while simultaneously harmonizing requirements, not only nationally, but internationally as well.

An important step in safeguarding product conformity and ensuring that a manufacturing or design process can consistently produce product of the required standard, is a structured management system. With regards to medical devices, there is no standard that better represents the requirements for a comprehensive management system than ISO 13485. Compliance with ISO 13485 is often seen as the first step in achieving compliance with regulatory requirements.

Increasingly, certification to ISO 13485 is becoming the preferred method for medical device manufacturers and their sub tier suppliers/contractors to demonstrate the intent to comply with applicable regulatory and statutory requirements. Medical device manufacturers who are placing their products on the market within the European Union will need to address compliance with the requirements of the applicable Medical Device Directive and the CE marking process. ISO 13485 is recognized as an aid in supporting compliance with the MDD.

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What our Learners are Saying

When was the last time you enjoyed learning? The only thing our students enjoyed more than the team exercises was our leadtutors. We’ve learned early on that when our experts enjoy what they are doing, the students do as well. Try us out and you’ll see the Kelmac difference.

Would Recommend
Kelmac Group®.

  • "I would highly recommend this training course for those who wish to become certified auditors and those who wish to learn more about the ISO 13485:2016 standard. The trainer, Gerard, was absolutely excellent and a mine of information. His wealth of experience and knowledge and real life auditor stories brought the material to life and really helped the learning experience."

    Caroline Fortune | 7th June 2017
  • "I got more than just the auditor training from this course, I got insight into the application of ISO 13485:2016 and it has been a valuable addition to my continuing professional education. "

    Eimear Butler | 31st May 2017
  • "Good teacher "

    Rolf Schmiegel | 24th May 2017
  • "Very good training material which is well structured, where the delivery of the course is well paced, and where group exercises help to re-enforce the learning experience along with good support from the trainers."

    Sushil Rajput | 16th May 2017
  • "The training with Kelmac was a great experience. Trainers are knowledgeable and have a broad range of experience. This allows for many practical and real world examples to be balanced with the theoretical elements of the ISO13485 content! "

    Thomas Casselden | 16th May 2017
  • "ISO 13485 training was great value and reinforced the key principles of auditing that can b applied to any industry / environmental where internal / external auditing is key to success. Gerard's experience and expertise was key to highlighting real-world examples."

    Christopher Chapman | 9th May 2017
  • "Excellent course well executed"

    Orla O'Brien | 5th May 2017
  • "The coupling between audit and leadership of excellence- and the being given methods to show the benefits of a quality system for top-management"

    Kristian Worziger | 4th May 2017
  • "An intensive but highly informative course. The instructor Gerard was extremely knowledgeable, very approachable and presented the course very clearly with emphasis on interactive group exercises. I would highly recommend the ISO 13485:2016 Lead Auditor course."

    Sharon Stapleton | 3rd May 2017
  • "I have learnt so much about auditing in five days. It has been a pleasure beeing instructed by Mr Kelly, he is so experienced in the field of auditing and medical device. With the six auditing phases as a roadmap I think I will be able to hang up the information efficiently and easily access it during the course of my career as an auditor. "

    Camilla Drott | 3rd May 2017
  • "The training was excellent. It was very intense and you would require a good knowledge of the standard prior to completing the training."

    Marie Walsh | 2nd May 2017
  • "Very logical insight into internal auditing, shows how you can put tools in place to assist in auditing and these can be built on over time. "

    Louise Heslin | 2nd May 2017
  • "Great and experienced instructors, friendly working atmosphere. Enjoyable training, even not easy course to pass. Hard work for all 5 days is needed. I can recomend also to all who have mother language other than English, however good understanding is needed. Ales (Prague, Czech Republic) "

    Ales Martinovsky | 30th April 2017
  • "Brilliant course with great practical examples."

    Serena Moore | 29th April 2017
  • "I am delighted that I decided to do this course. Instructors first class. "

    Elvyra Seskuviene | 29th April 2017
  • "Super Training in ISO 13485 and the practical implementation within organizations. "

    Lars Jensen | 28th April 2017
  • "The course was provided in a professional manner with interaction across the group encourage. Practical examples added value to understanding the practical aspects of the audit process"

    Paul O'Shea | 27th April 2017
  • "Concise information with great examples and interactive learning to make for an easy learning environment.Training tailored to meet the need of each students needs. Very enjoyable and beneficial course."

    Brendan Gamble | 25th April 2017
  • "The 2-day course was a good grounding for Internal Audits. Those with experience of Internal Audits benefited from some useful reminders."

    Christine Brooker | 21st April 2017
  • "Excellent delivery of a complex subject, instructor ensured all understood each section before moving on to the next one. "

    Hazel Gormley | 21st April 2017
  • "Very good course with very knowledge presenter"

    Chris Walsh | 20th April 2017
  • "I learned how to audit using the process and risk based approach and ISO 13485 2016"

    Mary Murtagh | 20th April 2017
  • "Learning in small Groups with Focus on the main topic - excellent"

    Stefanie Breisch | 18th April 2017
  • "Very good training, Thank you for all the effort and all the best"

    Michael Blinder | 7th April 2017
  • "Very thorough course, given by excellent trainers."

    Suzanne Condon | 5th April 2017
  • "This is an excellent course for companies that wish to obtain lead auditor certification. The tutor Gerard Kelly was very informative, and his level of knowledge and experience in Auditing is invaluable, and therefore would highly recommend the Kelmac Group as a course provider. I will be looking to complete other courses with the Kelmac Group in the future."

    Mandy Cashman | 5th April 2017
  • "Training was excellent. The detail provided an in depth understanding of ISO 13485"

    Patricia McCabe | 4th April 2017
  • "Overall , the course is very informative and delivered in a manner that the content is clearly understandable."

    Dermot Mohan | 30th March 2017
  • "Very good course, instructor was excellent."

    Aisling Reynolds | 30th March 2017
  • "Very good informative course. I have learned a lot about how to now properly conduct an Audit."

    Aisling Reynolds | 30th March 2017
  • "Very hands on approach with a lot of industry related examples"

    Agnieszka Sypula | 30th March 2017
  • "It was a very practical approach and hands on course with a lot of industry related examples"

    Agnieszka Sypula | 30th March 2017
  • "Extremely informative course, while it is quite intensive, the experienced instructors made it extremely relatable and interactive. "

    Yvonne Kelleher | 23rd March 2017
  • "The course was well organized and cover the topic thoroughly. The materials are very useful as they will come in need when the rules will have to be applied. The instructor was very well prepared, friendly and interactive. There were some exercises and activities to help the knowledge to sink in though I would like to have even more of them. The course was bit intense so I would rather have it one day longer but with more interaction and slower pace. However overall I would rate it as very good training experience. "

    Rut Klinger | 30th January 2017
  • "Amazing training course for people who is new in ISO standards!"

    Raymon Principe | 17th January 2017
  • "I was very impressed with the quality of delivery and competance of the instructor Prashanthi Kola. All trainees were kept focused in the training. The training was delivered with energy and positivity.The training on the second day was adapted to revelvant company requirements based on company information and requirements that Prashanthi picked up the first days training session."

    Larry Dillon | 17th January 2017
  • "The trainer had good presentation skills and interaction with participants. The Day 1 course material was very useful but additional material would have been useful for Day 2 (on IVDR). The knowledge of ISO 13485 was limited in this group so the pace of the course was most likely slower than normal but the trainer adapted to the audience quite well. "

    Sharon Stapleton | 17th January 2017
  • "It has been a good training. The technical knowledge of the instructor was excellent and I have got a good understanding in QMS Fundamentals based on ISO 13485:2016."

    Cesar Lopez Ruiz | 17th January 2017
  • "The traing was very beneficialto to me to understand ISO:13485:2016 as I am only new in my role for my company. The instucter was very clear and easy to understand and was very knowledgeable."

    Graham Bolger | 6th December 2016
  • "Course delivered in a professional manner, at the correct pace with the correct materials. Good understanding of the changes in the standard delivered."

    Olivia Kavenagh | 6th December 2016
  • "Course was excellent. Very informative. Instructors were great. I learn't a lot. "

    Diarmuid Crinion | 6th December 2016
  • "The instructor for the course Prashanthi Kola, was an excellent instructor. she was very well spoken , she answered any questions brilliantly. she thought the course in a way that you wanted to fully comprehend everything"

    Mark Farrell | 5th December 2016
  • "Kelmac group were professional and light hearted. would be good to have questionares that are easily answered or to have the tutor go through more of them. possibly a mock audit with a paragragh of non conformances."

    Vivien Munhui | 5th December 2016
  • "As the Operations Director of the company it gave me an indepth understanding of ISO-13485 from an operations point of view as well as a quality perspective. It gave me clear guidelines on how the company needed to continuously improve and how to do this. It offered an excellent method of using auditing for improvement not criticism. Overall, I would highly recommend this course to our sales team and our Management team."

    Shirley Walsh | 25th October 2016
  • "If you feel you have the skill to audit your company QMS to ensure the safety of the medical devices manufactured; by completing this course, you will receive the knowledge, method and direction to focus that skill to the benefit of the patient. "

    John O Donnell | 21st October 2016
  • "I found this course to be very good. It was very informative and with a small group we could go into alot more detail and depth. It was very good and the tutors knowledge was exceptional. I would highly recommend this course to others."

    Caroline Butler | 21st October 2016
  • "I would highly recommend KELMAC GROUP's ISO 134895:2016 Lead Auditor course. Professional instructor, effective training methods, interactive learning experience enable the students to achieve the course's objectives."

    Lily Goldstein | 25th July 2016
  • "The training is an advanced course, it demands a lot from a student (concentration, dedication, determination), however it is rewarding in the end. Individual becomes more confident in the subject matter, which results in better professional performance. "

    Anja Pavselj-Hafner | 6th July 2016
  • "I recommend this course for any one who wants to gain competence in Auditing career. Go for it, it is value for money."

    Ihuoma Alozie | 5th July 2016
  • "I was very lucky to get this training as the instructors are excellent and experienced for this medical device auditors field."

    Petr Bešťák | 4th July 2016
  • "The course was great, we learned a lot, but you need to be prepared to work hard and completely shut off your daily work for a week."

    MIRANDA ANGELOVSKI ČEBRON | 4th July 2016
  • "Excellent course, instructors are very knowledgeable and prepare you well for the exam. Learnt a lot in the week and would recommend for anyone interested in or already working in the medical device industry. "

    Maura Ryan | 4th July 2016
  • "I cannot recommend this course highly enough; the group exercises, individual exercises and role play allowed me to gain extensive knowledge in each aspect of the course. There was a great learning environment whereby everyone interacted with each other well and engaged with the instructors positively. The instructors Gerard and Prashanti were excellent and very approachable."

    Elaine Mc Partlan | 2nd July 2016
  • "This course was amazing. Even if you have no experience as a Auditor the course is delivered in a manner in which you are able to follow and learn."

    Rebecca Scott | 1st July 2016
  • "It was a well run event. The location and size of venue were appropriate to the number of attendees. The instructor made an excellent presentation."

    Tom Healy | 9th May 2016
  • "Very worth while overview of teh porposed changes in the standard. I woudl highly recommend attending this training."

    Fionnuala Gibbons | 29th April 2016
  • "This course was excellent and exceeded my expectations. I had forwarded the course to several of my current customers (3 of whom attended) and industry associates (2 of whom attended), and considering it was free of charge, I was concerned it would be used as a sales pitch. The fact that instead it truly educated the group whilst showcasing the knowledge level in Kelmac was a very successful morning for Kelmac (who I wasn't really aware of before) and a morning very well spent for the attendees - thank you"

    Rita Woodings | 25th April 2016
  • "Excellent course, delivered by an auditor (Gerard Kelly) with extensive knowledge and experience of Auditing Quality Management Systems."

    Genevieve Sherlock | 20th April 2016
  • "The presenter Gerard Kelly has an excellent grasp of his subject and many related subjects. No query or question was kicked to touch. His industry experience and passion for Quality comes through in his delivery. An excellent course on the QMS Fundamentals based on ISO 13485:2016. I would highly recommend him. I would be interested in similar courses on other ISO Certifications which are migrating to new standards."

    Gerry McNamara | 19th April 2016
  • "Very good overview of the topic. The course was more detailed and practical that I would have expected. A lot was covered in four hours. It was very useful in getting us started with the QMS updates and gap analysis. Exceeded my expectations."

    Orla Brennan | 19th April 2016
  • "Informative, informal, relaxed learning environment. "

    Marilla KEating | 19th April 2016
  • "There was excellent interaction between the instructor and the class and examples of experience really brought the point across. The class activities enhances ones confidence and learning on the subject matter. "

    Carmel Day | 25th February 2016
  • "I will highly recommend this course to any body. The instructor was so good and highly intelligent, friendly and ready to answer any questions. thanks so much I enjoyed every part of the training."

    Adaku Victoria Amazuo | 3rd February 2016
  • "The foundation course for the IRCA ISO13485 Lead Auditor Certification course is an essential to the actual 5-day course and provided much of the building blocks of knowledge that was required for the extended course. "

    Prashanthi Kola | 1st February 2016
  • "I have gained a lot of working Knowledge in completing this course regarding the ISO 13485 related to the Medical Device and Chemical Company. I will recommender this course to any one who want to be successful in this area."

    Elodie Ahamide | 1st February 2016
  • "The lead auditor course is an intensive introduction to the auditing process and this course leaves you with a strong understanding of the skill set required to fulfill the role of auditor."

    Ann Meenaghan | 30th January 2016
  • "Excellent course, well delivered, with plenty of practical information. Provided an excellent insight into the requirements of a Lead Auditor."

    Cheryl McCusker | 12nd January 2016
  • "This course help me fill in the gaps for areas that I was of certain about! This will help me portray a more professional, knowledgeable and confident auditor! "

    Don Fillion | 18th December 2015
  • " Excellent course, very relevant material. The knowledge and application of the instructors was very strong."

    Sandra Mullen | 23rd November 2015
  • "The course content received from the Kelmac group was excellent including practical insights in how to apply audits situations back to the ISO standard. The course tutor was very skilled using his previous experience in addition to the theory. I would recommend this course to others "

    Gareth McCullagh | 23rd November 2015
  • "Training on ISO13485 through the Kelmac group was an incredibly thorough and effective method to ensure that all participants recieved the best training in a suitable period of time."

    Philip Boylan | 19th November 2015
  • "Excellent course, the instructors were very knowledgable and really helped us to understand the correct clauses required. I would highly recommend this course"

    Rachal McKibben | 16th November 2015
  • "Can't rate the trainer any better, his experience and knowledge is immense and he gave plenty of real life examples which was helpful. The style of interactive teaching rather than power-point was brilliant, much better at keeping you engaged in the content. Learned loads that I will bring back to my work, and the course will hopefully help me to further my career. Would highly recommend Gerard and Kelmac to future employers. "

    Hazel Pearse | 26th October 2015
  • "Excellent course. Got exactly what I hoped for and much more. Very intensive and detailed, but well woth it. I learnt so much this week!"

    Mandie de Beer | 23rd October 2015
  • "The course provided attendees with a very good understanding of the need for risk management and the process of risk management. "

    Thomas Moore | 29th September 2015
  • "The trainer left us in know doubt that risk analysis is a very important part of the manufacture of medical products especially from a legal view point. He gave a detailed review of the different medical standards and what changes were coming down the line in the next year."

    Con Connolly | 23rd September 2015
  • "Informative course that requires active participation to get the most benefit."

    Marie Claffey | 23rd September 2015
  • "Good knowledgeable course with a strong focus on the importance of procedures and documents associated with Risk Management. Interaction with course coordinator and other course attendees was a plus rather than observing endless slides. "

    Cian O'Sullivan | 23rd September 2015
  • "A comprehensive conceptual, practical and applied training course on the ISO 13485 audit process…"

    Peter Harden | 8th July 2015
  • "I wish to have more time, because the information of content is very high. But otherwise a great and interesting experience from a component Tutor. The knowledge he has is outstanding."

    Poul Erik Pedersen | 7th July 2015
  • "with over 15yrs experience in the medical device field across all aspects, as a program manager I found it refreshing to attend a course that I learned something new. Gerry's in-depth knowledge of the subject matter were critical to the learning process and his delivery style was very open to questioning and collaboration. All aspects were well discussed and Gerry never at any point moved the group on until we were all happy with the clarifications. Excellent delivery, knowledge and it was a pleasure to attend"

    Ger Manley | 5th July 2015
  • "This five-day course was packed with learning activities in an interactive and dynamic style. I'm very glad that I realized that it would be very important to focus on the course and evening learning during the week, as this is an intense course. Thank you, Gerard, for a great week of learning!"

    Susan Alexander | 5th July 2015
  • "This course was very informative with an excellent mix of information about the standard along with supporting industry examples."

    Thomas Moore | 3rd February 2015
  • "Enjoyed the course, it was interesting and it was evident the trainer was an expert in this field which enhanced the course immensely."

    Barry O Farrell | 2nd February 2015
  • "Very experienced tutors, prepared to share their knowledge, made the training course very interesting and useful."

    Tadej Borstnar | 2nd February 2015
  • "The training and interaction with students on this course was excellent."

    Kenneth Kelleher | 2nd February 2015
  • "Intense course with the trainee obtaining a full knowledge of lead auditing to the ISO 13485 standard. Course is given by knowledgeable and approachable trainers and group interaction is very strong. "

    Elaine Feighery | 2nd February 2015
  • "If you are looking for training expertise, knowledge supported by substantial skill and ability, Kelmac are the organisation to deliver it."

    Declan Cahill | 1st February 2015
  • "Excellent course and very informative "

    Ger Butler | 26th January 2015
  • "I felt that the training was very useful and closely matched the information that I was interested in."

    Derek Allen | 26th January 2015
  • "Well worth doing for any company looking to get into the Med Industry"

    David Hannan | 25th January 2015
  • "I felt that the instructor came across very well and engaged with everyone extremely well"

    Tom Clancy | 21st January 2015
  • "Overall very good session."

    Nigel McKenna | 19th January 2015
  • "Excellent course, Gerard is really knowledgeable and great delivery. Really beneficial for all trainee's "

    Clem Mulcahy | 16th January 2015
  • "Instructor had excellent knowledge of the subject and kept me interested throughout"

    Liam Purthill | 16th January 2015
  • "Gerard was very knowledgeable and engaging. He provided many valued suggestions for us to improve our internal processes and be more prepared for any future audits."

    Lauretta Keyes | 16th January 2015
  • "Found the training very informative and instructor displayed an indept knowledge of the requirements of the subject matter."

    David Nihil | 16th January 2015
  • "The trainer was competent, very knowledgeably and to the point. Instructor’s flexibly adapted to the needs of the participants and during the workshop spent most time on the issues of most interest to us. The effectiveness and quality of the training and the competence and skills of the trainers were very high, really enjoyed the training, Agnieszka Piaskowska "

    Agnieszka Piaskowska | 11st September 2014
  • "Experience of trainer was communicated extremely well to a mostly inexperience room. Interaction rather than traditional presentations / lecturing style was extremely beneficial in keeping all participants engaged and effectively communicating the material "

    John O’Shea | 10th September 2014
  • "Very good course and extremely good instructor."

    Gerry Campbell | 9th September 2014
  • "The course was extremely helpful in terms of an overview of the 14971 standard, but was complimented by an experienced instructor who has experience of the on-going audit process. I would certainly recommended this as a starting point for professionals who have to work in conjunction with these requirements."

    Ronan Kennelly | 22nd July 2014
  • "Course was detailed and indepth. Good mixture of group activities and self directed study."

    Siofra Caherty | 17th July 2014

Not All Training Is Created Equal

The Kelmac Group® has developed a unique tradition of creating learning services that shape the future of conformity and compliance learning solutions for Executive Management, Practitioners and Auditors. Where others train followers, we train leaders™

Others train followers. We train leaders.™

Kelmac Group® specialise in Conformity & Compliance learning for Executive Management, Practitioners & Auditors. “The Ultimate Learning Experience”

Trusted Expertise

The quality of our Instructors is the cornerstone of our ability to serve our clients. Our people have real world practical experience and inspire confidence with Learners.

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Effectiveness Delivered

We are one of the few to objectively focus on and measure individual competency before, during and post-delivery. Many competitors make claims, we show results.

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Many training courses have a high focus on PowerPoint slides and information loading. We provide Learners the tools to grow, learn and become Leaders.

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No other training provider in Ireland has more training accreditations across a broader scope than Kelmac Group. Fact!

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Having worked in over 35 countries, we have experience that matters. A wealth of knowledge to share that is invaluable during training for those looking to learn from the best.

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We have a history of listening. A proven history of introducing many unique, world’s first offerings on the market including online & combined trainng courses.

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