Engineering & Quality Solutions, Inc. provides on-site training in a variety of topics related to design and development of medical devices. Our training courses allow your team to understand relevant requirements, learn best practices, and efficiently apply concepts to their projects immediately. Classes can be tailored to students’ needs based on team members experience and skill level.
Class Offerings
- Geometric Dimensioning & Tolerancing (GD&T)
- Defines the symbols, terminology & rules of Geometric Tolerancing per ASME Y14.5
- Translates geometric callouts into plain English with one meaning
- Best approaches to take when applying geometric tolerances
- Mechanical Drafting & Drawing Basics
- Introduction to orthographic projection & views
- Proper dimensioning & tolerancing techniques
- Understanding standard mechanical drawing layouts & notes
- Can be combined with GD&T class
- Design Verification & Validation for Medical Devices
- Requirements for medical device design verification & validation per FDA 21 CFR Part 820
- How to carry out & document effective design verification & validation
- Can be combined with Design Controls class
- Design Controls for Medical Devices
- Requirements for medical device design controls per FDA 21 CFR Part 820
- Defines the DHF elements: design inputs, design outputs, risk analysis and design verification & validation
- Strategies for effectively creating and maintaining design history files
- Customized Classes for Medical Device Industry
- Created for special requests and topics