Medical Devices: cGMP & Regulatory Affairs Training Courses and Professional Certification Programs
Document your dedication to medical device GxP compliance, consumer safety, and job performance by earning a professional training certification from Biopharma Institute.
Choosing Biopharma Institute to provide medical device regulatory or GxP compliance training demonstrates the importance you place on receiving a reliable, accurate, and high-quality instruction with an emphasis on producing products or services which are safe for the consumers or patients to use. Students earning a certificate of training from Biopharma Institute have an established appreciation for regulatory and compliance and have presented a strong understanding of the subject matter taught. Below is our list of training courses and professional certification programs for cGMP compliance and the regulation of medical devices.
Medical Devices:
Popular Programs & Training Categories
Popular Programs & Training Categories
- Professional Certifications:
- US Medical Device Quality Assurance (QA) Management Professional Certification Program
- FDA 21 CFR Part 820: Medical Device cGMP Professional Certification Program
- ISO 13485:2016 Professional Certification Program
- EU MDR: EU Medical Device Regulation for Professionals
- MDSAP: Medical Device Single Audit Program for Professionals
- Medical Device Validation for Professionals
- Regulatory Affairs: Introduction to the Regulation of Medical Devices
- EU MDR: EU Medical Device Regulation
- MDSAP: Medical Device Single Audit Program
- FDA 21 CFR Part 820: US cGMP for Medical Devices
- FDA Inspection Readiness (GMP Auditing)
- ISO 14971:2019 Medical Devices
- ISO 13485:2016 Medical Devices
- ISO 14155:2020 Clinical Research of Medical Devices Standard
- Validation of Medical Devices
- Change Control: Systematic Method to Manage Change
- Root Cause Analysis & CAPA
- cGMP for Beginners
- cGMP for Combination Products: Pharmaceuticals & Medical Devices
- China CFDA: cGMPs
Subcategories (Areas of specialty or focus):
Medical Device Courses and Programs:
Core Medical Device Programs & Courses:
![]() |
21 CFR Part 820: Medical Device cGMP Professional Certification ProgramCourse ID: MDPROAverage Learning Time: See Program Webpage Price: $1995 | Learn More |
|
![]() |
ISO 13485:2016 Professional Certification ProgramCourse ID: ISOPCRTAverage Learning Time: See Program Webpage Price: $1295 | Learn More |
|
![]() |
ISO 14971:2019 for ProfessionalsCourse ID: ISOPROAverage Learning Time: See Program Webpage Price: $995 | Learn More |
|
![]() |
EU Medical Device Regulation (EU MDR) for ProfessionalsCourse ID: EUMDRAverage Learning Time: See Program Webpage Price: $1295 | Learn More |
|
![]() |
Medical Device Single Audit Program (MDSAP) for ProfessionalsCourse ID: MDSAPAverage Learning Time: See Program Webpage Price: $1195 | Learn More |
|
![]() |
Medical Device Validation for ProfessionalsCourse ID: MDVALAverage Learning Time: See Program Webpage Price: $495 | Learn More |
|
![]() |
Introduction to the Regulation of Medical DevicesCourse ID: MDA0Average Learning Time: 60 minutes Price: $195 | Learn More |
|
![]() |
ISO 14155:2020 Medical Device StandardCourse ID: CP008aAverage Learning Time: 45 minutes Price: $199 | Learn More |
21 CFR Part 820 cGMP Medical Device Programs:
![]() |
cGMP: Introduction to Good Manufacturing Practice, An Abridged CourseCourse ID: GMP00Average Learning Time: 10 minutes Free Course: Start Learning, Today! Learn More |
|
![]() |
GMP: 21 CFR Part 820 Subpart A – General ProvisionsCourse ID: ELM-301Average Learning Time: 30 minutes Price: $199 | Learn More |
|
![]() |
GMP: 21 CFR Part 820 Subpart B – Quality System Requirements (QSR)Course ID: ELM-302Average Learning Time: 30 minutes Price: $199 | Learn More |
|
![]() |
GMP: 21 CFR Part 820 Subpart C – Design ControlsCourse ID: ELM-303Average Learning Time: 45 minutes Price: $199 | Learn More |
|
![]() |
GMP: 21 CFR Part 820 Subpart D – Document ControlsCourse ID: ELM-304Average Learning Time: 45 minutes Price: $199 | Learn More |
|
![]() |
GMP: 21 CFR Part 820 Subpart E – Purchasing ControlsCourse ID: ELM-305Average Learning Time: 45 minutes Price: $199 | Learn More |
|
![]() |
GMP: 21 CFR Part 820 Subpart F – Identification and TraceabilityCourse ID: ELM-306Average Learning Time: 60 minutes Price: $199 | Learn More |
|
![]() |
GMP: 21 CFR Part 820 Subpart G – Production and Process ControlsCourse ID: ELM-307Average Learning Time: 45 minutes Price: $199 | Learn More |
|
![]() |
GMP: 21 CFR Part 820 Subpart H – Acceptance ActivitiesCourse ID: ELM-308Average Learning Time: 45 minutes Price: $199 | Learn More |
|
![]() |
GMP: 21 CFR Part 820 Subpart I – Nonconforming ProductsCourse ID: ELM-309Average Learning Time: 60 minutes Price: $199 | Learn More |
|
![]() |
GMP: 21 CFR Part 820 Subpart J – Corrective and Preventive ActionCourse ID: ELM-310Average Learning Time: 45 minutes Price: $199 | Learn More |
|
![]() |
GMP: 21 CFR Part 820 Subpart K – Labeling and Packaging ControlCourse ID: ELM-311Average Learning Time: 45 minutes Price: $199 | Learn More |
|
![]() |
GMP: 21 CFR Part 820 Subpart L – Handling, Storage, Distribution and InstallationCourse ID: ELM-312Average Learning Time: 45 minutes Price: $199 | Learn More |
|
![]() |
GMP: 21 CFR Part 820 Subpart M – RecordsCourse ID: ELM-313Average Learning Time: 45 minutes Price: $199 | Learn More |
|
![]() |
GMP: 21 CFR Part 820 Subpart N – ServicingCourse ID: ELM-314Average Learning Time: 45 minutes Price: $199 | Learn More |
|
![]() |
GMP: 21 CFR Part 820 Subpart O – Statistical TechniquesCourse ID: ELM-315Average Learning Time: 45 minutes Price: $199 | Learn More |
Additional Medical Device Courses Not Listed Above
- EU MDR: Individual Courses
- MDSAP: Individual Courses
- FDA Inspection Readiness (GMP Auditing) Individual Courses
- ISO 14971:2019 – Individual Courses
- ISO 13485:2016 – Individual Courses
- Validation of Medical Devices – Individual Courses
- cGMP for Combination Products: Individual Courses
- China CFDA: cGMPs
Online Training – The Benefits of eLearning:
- Immediate access to courses: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
- Self-paced, asynchronous eLearning: 24/7 access to individual courses for 6 months and 1 year for professional certification programs.
- Expertise: Courses have been developed by subject matter experts (SMEs) in the area of material being taught.
- Current and validated: Courses are current with respect to regulations, procedures, and are 3rd party validated and/or accredited.
- Optimized for learning: Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter.
- Secure and safe access: Website and LMS provide an encrypted connection, including firewall protection and daily scans for malware, to deliver optimal level of security and performance.
- Flexible final assessments: Assessments include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
- Direct access to certificates: Certificate of completion is instantly available once requirements have been fulfilled.
- Verification of training: Certificates can be verified online, and digital badges are issued for all professional certification programs.
- Training manager access: Our proprietary Training Manager Portal offers managers access to download their group enrollments, training records, account balance, and so much more.
- SCORM-compliant courses: Courses can be delivered directly from most corporate Learning Management Systems (LMS).
- Purchase orders (POs): POs are accepted from all companies. You must request an invoice to start the procurement process.
- Reimbursement: Some employers may reimburse their employees for training expenses. Check your company’s education reimbursement policy.
- Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. Alternatively, purchasing individual courses one at a time is also an option.
- Career advancement: Professional certifications help demonstrate interest and dedication to your career and job performance. They may be helpful for those seeking a new career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer taking points for the interview, and practical knowledge for performing the work.
Have Questions? Contact Us:
Use the form below if you would like more information on our programs. You may want to request a quote on group training or an invoice for generating a company purchase order. For quotes or invoices please provide the course(s) and number of students. Alternatively, call toll-free from the US or Canada: +1 (888) 424-6576. International callers may dial: +1 (201) 301-8370.