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On-Site Group ISO 13485 Training for Medical Device Manufacturers

This ISO 13485:2003 employee training class is conducted on-site by a senior QA consultant from Emergo. Our QMS consultants are all trained Auditors with extensive auditing and manufacturing experience across various device types and quality systems. This ensures that your team will get a high quality ISO 13485 training session tailored to the needs of your organization. This ISO 13485 training is usually conducted at your facility but can be held at a nearby off-site facility of your choosing.

Interested in upgrading to ISO 13485:2016? See how we can help.

Customized on-site ISO 13485 training for a fixed price, regardless of how many employees attend.

Our fee for ISO training is based on a set daily fee plus travel expenses. This makes it a great value for companies that need to train two or more employees at one time. On-site training gives your employees the opportunity to ask questions (something they cannot do easily with online classes) and ensures that every employee is receiving consistent information at the same time.

What your team will learn in this intensive one day ISO 13485 awareness training class:

  • Overview of the ISO 13485:2003 standard and the implications to your company.
  • Benefits of adopting the ISO 13485 standard.
  • The responsibility of senior management.
  • Personnel inside your company who will be involved in implementation.
  • Personnel who will be involved on an ongoing basis.
  • Why the process approach makes sense.
  • Setting measurable quality objectives and defining responsibilities.
  • How ISO 13485 impacts the roles of design and development, purchasing, production, customer communications and other teams.
  • Document control and record keeping.
  • Incorporation of risk management activities throughout the device lifecycle.
  • Process validation, monitoring and traceability, control of measurement devices, environmental controls and data analysis.
  • Monitoring and maintaining the effectiveness of the quality system: how and why.

Optional: Additional days may be added to incorporate how the standard relates to other international regulations including registration requirements in various markets such as Canada, the EU, Australia and others.

Please contact us for more information on group ISO 13485 training at your facility.

Ask us for detailed information about ISO 13485 training services.

Learn about the process, costs and timelines.

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