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™

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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.

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  • "An intense but very enjoyable learning experience hosted by an extremely passionate subject matter expert vastly experienced in actual application of iso13485 as a lead auditor."

    Chris Felton | 18th March 2015

  • "Demanding and supporting training environment that forced me to achieve the learning objectives."

    Patrick Manouvriez | 16th March 2015

  • "Just thank you for good training..."

    Miroslav Vasko | 16th March 2015

  • "Fast paced, excellent learning environment."

    Sharon Shreeves | 16th March 2015

  • "Excellent course which imparted the knowledge and some of the skills associated with a lead auditor's role but also set that role in the context of the modern business environment and provided a look forward to coming changes."

    Patrick Hull | 16th December 2014

  • "I would highly recommend this course. The combination of course work, instructor knowledge & guidance and how to apply the standard was a very effective way to learn!"

    Dharmesh Vara | 10th November 2014

  • "Great training, but we ran out of time in the end and a few things were left out e.g. how to train/register with the IRCA. Overall, the course was delivered well by an engaging tutor and I enjoyed participating. "

    Sheila Kondaveeti | 10th November 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”

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