ISO 13485 Training for Medical Device Companies - 1 or 2 DAYS
This ISO 13485:2003 training class is conducted on-site by a member of Emergo Group’s team of quality and regulatory professionals. Our training consultants are Certified Lead Assessors with real world manufacturing experience, not slick “canned” presenters. This ensures that your team will get a high quality ISO 13485 training session tailored to the needs of your organization. This ISO 13485:2003 training can be conducted at your facility, a local hotel meeting room or another facility of your choosing.
Professional, on-site ISO 13485 training for one fixed fee, regardless of how many employees attend!
Our fee for training is based on a set daily 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 can’t do easily with pre-packaged online classes) and ensures that every employee is hearing consistent information at the same time.
What your team will learn in this intensive one day ISO 13485 training class:
- Overview of the ISO 13485:2003 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.
- Creating the quality policy manual.
- Continuous improvement, how and why.
- Process validation, monitoring and traceability, control of measurement devices and data analysis.
- Plus much more.
Optional: Day 2 provides an in-depth look at how to properly audit your quality system and an overview of CE Marking requirements.
