We offer training for you and your team
We offer Custom Training for your Team
Do you need training for the new Risk Management Standard? Do you need custom training for a new product launch? Whatever you need, we can work with your team to create a web-based training.
- Complaint Training (Organization)
- Measurement and Calibration
- Quality System Training (FDA and ISO 13485:2016)
- ISO 13485:2016 Lead Auditor Training
- Good Clinical Practice Training (GCP)
We have content experts in Regulatory, Quality, Product Development, and Clinical Research. Our subject matter experts use their skills on a daily basis, they are not consultants with dated experience. We understand your problems because we face the same obstacles every day.
E learning Experts
We have an in-house team of eLearning experts and established resources that can create engaging, interactive content to bring your training to life.
We love to help!
One of the most frequent FDA findings is an organization’s failure to handle complaints correctly and timely. This course provides your entire organization a quick and effective reminder of the importance of reporting complaints promptly. This is a practical training designed to engage, reinforce, and help the whole team understand the importance of complaint handling.
25 minutes; self-paced; final assessment with a certificate upon passing.More Info
Quality Systems Training (FDA 21CFR820 and ISO 13485:2016)
Designed for both individuals and quality teams working in the medical device field, this course covers every aspect of essential standards and presents users with case studies and effective solutions. This training provides a solid foundation to build a better understanding as to why each regulation exists. We know that discussing the whys and hows of requirements provides actual value, that is why this training is much more than just “here are the rules, learn them.” Our team assumes you can read.
In addition, this class has “office hours,” where attendees can discuss specific questions in confidence with a medical device quality expert.
Self-paced; final assessment with a certificate upon passingMore Info
Measurement and Calibration
What every manager, engineer, and technician needs to know about measurements and calibration of systems. How do you know if your system has the right capability, traceability, and stability? What needs to be calibrated? How often? Best methods? Standards?
Expert Instructor led. Over 20+ years of experience with medical device systems. Get your specific questions addressed in class.
4-hour webinar; final assessment with a certificate upon passing.Apply Now
ISO 13485:2016 Lead Auditor Course
Perfect for any individual in the medical device field, this comprehensive training covers every element of conducting an audit, case studies, and real-world solutions. This course will provide you with extensive knowledge and auditing experience.
“Office hours” are also offered for attendees to discuss questions in confidence with a certified auditor during and after the course. Additionally, there will be a live assessment by a Certified Auditor as part of the final assessment.
16-20 hours; self-paced; final assessment with a certificate upon passing.Apply Now
Good Clinical Practices (GCP)
Geared towards individuals in the medical device field, especially those in clinical research, this course covers all clinical research standards: FDA regulations (IDE, IRBs, etc.), ICH E6, and other international standards. You will be presented with case studies and effective, practical solutions. Providing a comprehensive background and discussing real world implications will build a better understanding as to why each regulation exists. We know that discussing the whys and hows of requirements provides actual value, that is why this training is much more than just “here are the rules, learn them.” Our team assumes you can read.
In addition, this class has “office hours,” where attendees can discuss specific questions in confidence with a medical device Clinical/Regulatory Expert.
8 to 12 hours; self-paced; final assessment with a certificate upon passing.Apply Now