mdi Consultants, Inc, is excited to announce a new program for the medical device industry.
mdi has set up a set of ON-DEMAND training programs allowing companies to provide their employees with several training programs on relevant FDA issues: QSR compliance, CAPA and Design Control.*
Each program runs 1 to 1.5 hours and has a question and answer session allowing the participant to get a certificate of training once they successfully pass the test.
*Return to this page often for information on new training programs.
The FDA QSR/cGMP requirements for medical device companies
A basis overview of the FDA regulatory requirements for the medical device industry and an introduction into the QSR/cGMP requirements for any medical device manufacturer.
Design Control: What you need to comply with the FDA
A basis understanding of the FDA Design Control requirements and what is required by a medical device company to implement a design control procedure and meet the FDA requirements.
CAPA: Complaints, MDR and Installation
An understanding of the CAPA requirements in the FDA QSR/cGMP and what is necessary to deal with complaints, MDRs and device installation.
About The Test
To pass the test requires correctly answering 16 of the 20 questions. If the test is not passed, both the training course and the test must be retaken.
When the test is passed, an individually serialized certificate of training is issued.
Who should take the course:
- All medical device company’s employees wanting a basic understanding of the FDA regulatory requirements concerning the QSR/cGMP, Design Control and CAPA.
- New employees to the medical device industry to have an understanding of what the FDA is and the regulatory requirements they would be responsible for.
- To prepare the staff for any upcoming FDA inspection, in order to have a better understanding on what to expect during the FDA audit.
$95.00 per course, per person
Begin Online Training The course has been reviewed by former and present USFDA officials. The mdi training program has been found to cover all aspects of the regulations and has been determined to be an excellent training for all medical device industry employees from the Officers of the company to the production staff.