 CfPIE is pleased to offer the very first general compliance certification for Medical Device professionals! The Certified Medical Device Compliance Professional (CMDCP) program is designed to give industry personnel the kind of robust compliance training needed to advance their careers and satisfy the requirements of regulators and your own internal audits. From quality and manufacturing concerns to product design, clinical trials, validation and regulatory filings, you can be sure to select the path that best suits your current responsibilities and career goals.
Participation is simple. Attend three core courses and one elective from the list below. Complete the accompanying tests, maintain an average score of 70 percent and CfPIE will issue your credentials. There is no formal application process and there are no prerequisites or additional fees required to participate.
Core Courses (Choose Three):
- Overview of FDA Regulatory Compliance For Medical Devices
- Medical Devices: EU Directives, Guidance, CE Marking and ISO Standard Certifications
- Labeling and Labeling Controls in the Medical Devices Industry
- Design Control for Medical Device Professionals
- Design Validation, Verification, and Risk Analysis for Medical Device Professionals
- Process Validation for Medical Devices
- Quality System Regulation for the Medical Device & Biotech Industries
- Clinical Trials Design for Medical Devices
Elective Courses (Chose One):
- How to Develop an Effective Complaint Handling and Post Market Surveillance Program for Drugs and Devices
- How to Implement Risk Management Principles and Activities Within a Quality Management System
- FDA Inspections: What To Expect & How To Prepare
- European Filing & Registration Procedures
- The EU Clinical Trial Directive
- Effective Quality Assurance Auditing
- Effective Document Management for the Pharmaceutical, Biotech & Medical Device Industries
- Root Cause Analysis for CAPA
- Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries
- Validation of Computer Systems
- Writing Effective Standard Operating Procedures and Other Process Documents
- Practical Methods for Project Management
- Auditing and Qualifying Suppliers and Vendors
All certification tracks are developed and vetted by a committee of industry experts, many of which are former FDA or international regulators. To find out more, visit our Frequently Asked Questions page or call 1-610-688-1708. Visit our Medical Device courses by type page or our courses by date page for schedules.
If you have multiple staff that would benefit from this certification, we can offer these programs at your facility as part of a "certification series." For more information, contact us at +1-610-688-1708 or email us at info@cfpie.com.
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