Course Titles/Topics:

• Design Control Compliance for FDA & ISO
• Risk Management, ISO 14971 and FDA Requirements
• Software Compliance and V&V for FDA & ISO
• IEC 60601-1 the 3rd Edition: Certification Requirements & How to get Certified
• Complaints, Medical Device Reports (MDRs) & CAPA
• FDA Quality System Regulation (QSR/GMP) & FDA Inspections
• ISO 13485:2016 Towards a Global Quality System
• 510(k) Submissions: How to Prepare & Get FDA Clearance
• CE Marking Medical Devices & IVDs
• Auditing Quality Systems: for FDA & ISO Compliance
• Process Validation for FDA & ISO Compliance
• Writing Effective Technical Product Requirements (please contact us for information)
• Labeling Requirements & Guides for Medical Devices (please contact us for information)
• FDA Electronic Recordkeeping & Signatures (21 CFR Part 11)

On-Site or Virtual Training Inquiry Form

or call 949-398-5222 or e-mail for details!

On-site courses are typically offered in condensed one day (full day) courses so that time away from the job and other commitments can be minimized. Virtual courses can be taught over multiple days, e.g. 4 hours per day for 2 days. Optional workshop days allow the attendees to work on topic related examples specific to the company, such as new projects or products to be developed, and result in useable work product being produced which can considerably accellerate a project.

An optional assessment (test/quiz) will be administered allowing each participant to receive a certificate awarding Continuing Education Units (CEU) that can be used to document employee training and competency per FDA GMP/QSR and ISO 13485. A professional binder of course materials and handouts will be made available electronically with print copies available as an option. The company will receive a training assessment report documenting the training and everyone in attendance which will be helpful during a regulatory audit by FDA or your notified body.

As an additional option, you may want to consider follow-up or preparatory consulting (documentation and procedure reviews, etc) or an independent compliance audit either before or after the course so that you can obtain a baseline for improvement to your company's current compliance with regard to regulatory requirements. An estimate of the time required and hourly rates will be provided at your request. If you desire to schedule an in-house course, please contact us as soon as possible. For live on-site training, travel schedules for our course directors are rigorous and can make it difficult to schedule courses with short notice. However, do not delay in contacting us as sometimes short notice requests can be accommodated. For more information including a price schedule please use our On-line Request Form or e-mail or call us at 1-949-398-5222.

*Confidentiality Agreements will be signed by our course directors upon request.