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ISO 13485 Certification Training Course
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.
Kelmac Group`s Understanding ISO 13485 training course gives delegates a broad understanding of the quality management system requirements outlined in the medical devices standard ISO 13485 requirements
IRCA Approved ISO 13485 Lead Auditor Training Course
This IRCA Certified comprehensive five-day course provides hands-on training to ensure that your lead auditor thoroughly understands the role and acquires the expertise needed to perform it effectively.
Internal QMS Auditor Refresher Training Course
This course is designed to provide existing internal auditors with refresher training on the latest updates and changes relating to the field of internal auditing. It is recommended that internal auditors attend refresher training every 3 years to remain up to date with the latest best practice plus any changes/updates that may have occured among various standards that are applicable to the field of auditing.
Medical Devices Risk Management Overview based on ISO 14971:2012 Training Course
This course provides a thorough introduction and interpretation of ISO 14971 risk management, throughout the product lifecycle, including a summary of the latest changes to the standard.