ISO 13485 Training for Medical Device Companies

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This ISO13485:2003 training class is conducted on-site by a member of Emergo Group's team of quality and regulatory professionals. Our training consultants are all trained Auditors with extensive auditing and manufacturing experience across various product types and quality systems. This ensures that your team will get a high quality ISO13485 training session tailored to the needs of your organization. This ISO13485 training is usually conducted at your facility but can be held at a nearby off-site facility of your choosing.

Professional, on-site ISO13485 training for one fixed fee, regardless of how many employees attend.

Our fee for training is based on a set fee plus 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 ISO13485 awareness training class:

• Overview of the ISO13485:2003 standard and the implications to your company.
• Benefits of adopting the standard and regulatory requirements.
• Why the process approach makes sense.
• Setting objectives and defining responsibilities.
• Who needs to be involved within the company.
• The responsibility of senior management.
• Role of design and development, purchasing, production, record keeping, customer communications.
• Maintaining effectiveness of the quality system, how and why.
• Process validation, monitoring and traceability, control of measurement devices and data analysis.

Optional: Day 2 provides a more in-depth look at ISO13485 and how it relates to other international regulations including registration requirements in various markets.

Please contact us for more information or a free proposal on ISO13485 training at your facility.