For any professional in the medical devices industry; training is a must. This training has to be on the regulatory aspects of the industry profession, because this is at the root of the profession. Medical devices being one of the most regulated industries, a professional in this industry is governed by a slew of regulations.
Medical device regulatory compliance training is thus necessary to help them achieve two ideals: one, to enter the profession, and two, once they are part of the profession, to keep updating their skills and knowledge, since this an ever-changing field. New technologies and other developments warrant new regulations. So, medical device regulatory compliance training is essential for anyone in the profession to both start and to advance in it.
Who carries out medical device regulatory compliance training?
The FDA authorizes a few select certifying bodies to carry out medical device regulatory compliance training. It sets out the nature, as well as the other technicalities such as syllabus, duration of course, rewards system and so on. The authorized certifying body then runs the course that addresses the requirements of medical device professionals. Many of these certifying bodies carry out these designated, authorized trainings in a number of formats, which professionals can choose from based on their convenience and need.
What do these courses contain?
Being authorized courses, the medical device regulatory compliance training courses from authorized certifying bodies cover nearly all areas of compliance training for medical devices. There are a few core subjects as well as a few optional ones. Generally, although not necessarily, most courses consist of these training syllabi:
- Overview of FDA Regulatory Compliance for Medical Devices
- Design Control
- Design Validation, Verification, and Risk Analysis
- Medical Device Submissions – 510ks, PMAs, and Exemptions
- Process Validation
In addition, professionals enrolling for medical device regulatory compliance training can choose from a range of electives. Typically, they are offered the option of choosing one among:
- FDA Inspections
- Post Market Surveillance and Complaint Handling Systems
- EU Directives, Guidance, CE Marking and ISO Standards Certifications
- Recalls, Product Recovery and Safety Alerts
- Risk Management
- European Regulatory Procedures
- Auditing and Qualifying Suppliers and Vendors
- Computer Systems Validation
- Document Management
- Quality Assurance Auditing for FDA Regulated Industries
- Writing Standard Operating Procedures and Other Documents
- The EU Clinical Trial Directive
- Technical Writing for the relevant industries
- Root Cause Analysis of Failures & Deviations – Developing CAPA Strategy
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