About ISO 13485:2003 - Medical Devices Quality Management

The medical device industry is affected by a complex array of regulatory systems, national and international standards and other requirements. We provide services that help manufacturers understand what they need to do to place compliant devices on markets throughout the world.

ISO 13485:2003 is the latest version of ISO 13485, published in July 2003.  This standard is based on the ISO 9001:2000 process model approach.

Whatever devices you produce, as a medical device manufacturer you have a responsibility to consistently deliver devices that are safe and effective. ISO 13485:2003 is the international standard recognized for medical device regulations around the world.

Training on ISO 13485

Kelmac Group offer training courses on ISO 13485 covering:

• Executive Overview Training (0.5 day)
• Foundation Level Training (1 day)
• Internal Auditor (2 or 3 days)
• Auditor/Lead Auditor Training (5 days)
• Implementation Training (3 or 4 days)
• Tailored/Incompany Training

Full course information available by clicking here

For more information and/or a competitive quotation on any training solution, please do not hesitate to contact us.