Certification · Medical Devices
Medical Device Regulatory Affairs Course
Learn how medical devices are classified, tested in clinical investigations and approved — from EU MDR and ISO 14155 to clinical evaluation reports and post-market follow-up. Live online, taught by Dr. Kanika Mahajan.
- Duration
- 40 hours
- Mode
- Live Online
- Next batch
- Ask an advisor
- Certificate
- BCRI certificate
Course fee₹28,000₹35,000
- LSSSDC · NSDC · Skill India training partner
At a glance
What is medical device regulatory affairs?
BCRI’s Medical Device Regulatory Affairs course is a 40-hour live online programme for life science, pharmacy, biomedical and engineering graduates who know clinical research basics. It covers EU MDR, ISO 14155 device GCP, clinical investigations, clinical evaluation (CEP, CER, PMCF), post-market surveillance, and India’s CDSCO and US FDA routes, with hands-on document practice.
Every medical device — from a syringe to a heart valve, a glucose monitor or medical software — must meet strict rules before patients can use it. Medical device regulatory affairs is the work of proving that a device is safe and performs as claimed, and keeping that proof up to date for as long as the device is sold.
The rules for devices are different from the rules for medicines. Devices are classified by risk, tested in clinical investigations under ISO 14155 rather than ICH GCP, and backed by a living clinical evaluation report. In Europe this is set by the Medical Device Regulation (EU MDR 2017/745), in India by the Medical Devices Rules, 2017, and in the US by the FDA.
This course follows a device from start to finish: classification, clinical strategy, study design, the clinical investigation plan, ethics and regulatory approval, study conduct, monitoring, safety reporting, clinical evaluation and post-market follow-up. You practise the real documents device teams write every day.
Last updated
Why BCRI
Why choose BCRI for your medical device regulatory course?
Device GCP (ISO 14155)
Learn the device version of GCP: sponsor, investigator and monitor duties, the CIP, consent and safety reporting.
Clinical evaluation
Write a Clinical Evaluation Plan and Report: literature search, appraisal, equivalence, benefit-risk and PMCF.
EU MDR end to end
Classification, economic operators, technical documentation, conformity assessment, UDI/EUDAMED, labelling and PMS.
India & US routes
CDSCO licensing under the Medical Devices Rules, 2017, and FDA 510(k), De Novo, PMA and IDE basics.
Expert trainer
Taught live by Dr. Kanika Mahajan, PhD, with 9+ years in clinical research and device regulatory work.
Placement assistance
Resume help, mock interviews and job referrals from the placement team.
Skills you will gain
- Classify a device under EU MDR rules and understand the matching conformity assessment route
- Apply ISO 14155:2020 to plan and run a medical device clinical investigation
- Draft key study documents: Clinical Investigation Plan (CIP), Investigator’s Brochure, informed consent
- Prepare ethics committee and regulatory submissions, and handle substantial modifications
- Report adverse events and device deficiencies on the right timelines
- Write a Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER), including equivalence and benefit-risk
- Plan post-market clinical follow-up (PMCF) and post-market surveillance (PMS)
- Understand technical documentation, ISO 13485 QMS and ISO 14971 risk management in a device file
Curriculum
Medical device regulatory course syllabus
Ten modules and a capstone that follow a device from classification to post-market follow-up.
- Modules
- 11
- Topics
- 36
- Duration
- 40 hours
Want the detailed syllabus?
An advisor will share the full module plan on WhatsApp or email.
Get the syllabus1
Medical Devices and the Regulatory Landscape
3 topics- What counts as a medical device (incl. software and IVDs) and how devices differ from drugs
- Global overview: EU MDR & IVDR, India Medical Devices Rules 2017 (CDSCO), US FDA, IMDRF
- Device life cycle and the roles of manufacturer, authorised representative, importer and distributor
2
EU MDR Essentials
4 topics- Risk classes I, IIa, IIb and III and the classification rules
- General Safety and Performance Requirements (GSPR)
- Notified bodies and conformity assessment routes
- UDI, EUDAMED, labelling and Instructions for Use (IFU)
3
QMS, Risk Management and Technical Documentation
3 topics- ISO 13485 quality management system basics
- ISO 14971 risk management and the link to clinical data
- Structure of the technical documentation (MDR Annex II & III)
4
ISO 14155 — Good Clinical Practice for Devices
3 topics- Principles, ethics and the differences from ICH GCP
- Responsibilities of sponsor, principal investigator and monitor
- Essential documents and the investigator site file
5
Planning a Clinical Investigation
3 topics- From device to clinical strategy: when a clinical investigation is needed
- Study design, endpoints and the Clinical Investigation Plan (CIP)
- Investigator’s Brochure and informed consent for device studies
6
Approvals and Study Start-up
3 topics- Ethics committee and regulatory submissions (EU MDR Article 62–82; CDSCO in India)
- Site selection, feasibility and site initiation
- Substantial modifications and their approval
7
Study Conduct, Monitoring and Safety Reporting
4 topics- Monitoring plans, monitoring visits and audits
- Adverse events, serious adverse events and device deficiencies
- Reporting timelines (MDCG 2020-10/1) and documentation
- Data management and the Clinical Investigation Report
8
Clinical Evaluation (CEP & CER)
4 topics- Clinical Evaluation Plan and the sources of clinical data
- Literature search, appraisal and analysis of clinical data
- Demonstrating equivalence (MDCG 2020-5) and deciding whether a clinical investigation is needed
- Benefit-risk conclusions and writing the Clinical Evaluation Report
9
Post-Market Surveillance and PMCF
3 topics- PMS plan, PMS report and Periodic Safety Update Report (PSUR)
- Post-market clinical follow-up: PMCF plan and evaluation report (MDCG 2020-7, 2020-8)
- Vigilance and field safety corrective actions
10
India CDSCO and US FDA Routes
3 topics- India: device classes A–D, licences and clinical investigation under the Medical Devices Rules, 2017
- US: 510(k), De Novo and PMA pathways; IDE for device studies (21 CFR 812)
- Comparing the evidence each market expects
11
Capstone and Assessment
3 topics- Classify a sample device and map its approval route
- Draft sections of a CIP and a CER for the same device
- Prepare a PMCF plan outline
Meet your trainer
Dr. Kanika Mahajan
Lead trainer, Medical Device Regulatory Affairs
Dr. Kanika Mahajan is a clinical research and regulatory affairs professional with 9+ years of experience, from early research to clinical trials and regulatory submissions. She has coordinated Phase I–IV clinical investigations of medical devices and managed regulatory submissions under EU MDR 2017/745.
- Medical device clinical investigations
- EU MDR submissions
- Regulatory documentation
- Good Clinical Practice
- Biostatistics
Fees & batches
Medical Device Regulatory Affairs fees and upcoming batches
Course fee
₹28,000₹35,000Save ₹7,000
40 hours · Live online, with recordings and notes
What’s included
- Live interactive online classes
- Industry-expert trainer
- Hands-on CIP, CER and PMCF practice
- Class recordings and notes
- Certificate on completion
- Resume, interview and placement assistance
Paying the full fee online? Choose “Pay in full online” when you apply and get 5% off. Instalment options are available — ask an advisor.
Compare all course fees →Upcoming batches
New batches start every month — online and at HSR Layout.
Classes run Monday to Friday. Ask an advisor for the next start date.
- Monday–Friday classes
- Recordings for online batches
- Online or HSR Layout, Bengaluru
- Instalment options available
Certification
Medical device regulatory affairs certification
On completion you receive the BCRI certificate in Medical Device Regulatory Affairs. Assessment is assignment-based, built around the capstone documents.
This course gives the BCRI certificate only; it is not part of BCRI’s Dual Certification with LSSSDC.
What your certificate shows
- Certificate of CompletionIssued by Bangalore Clinical Research Institute
- Core modules completedEU MDR · ISO 14155 clinical investigations · Clinical evaluation & PMCF
- Registration numberUnique to you and verifiable online
Recognition marksISO 9001:2015
Careers & salary
Career opportunities after the medical device regulatory course
Medical device companies, device CROs and notified bodies need people who understand both the regulations and the clinical evidence behind a device. EU MDR made clinical evidence and post-market follow-up stricter, and India now licenses all device classes, so demand for device regulatory and clinical affairs skills is growing.
Job roles you can apply for
- Regulatory Affairs Associate (Medical Devices)
- Clinical Affairs Associate / Specialist
- Clinical Evaluation Specialist / CER Writer
- Clinical Research Associate (device studies)
- PMS / Vigilance Specialist
- Quality & Regulatory Associate (ISO 13485)
Where you can work
- Medical device manufacturers
- Device CROs
- Regulatory consultancies
- Notified bodies and testing organisations
- Diagnostics (IVD) companies
Hiring locations
- Bengaluru
- Hyderabad
- Pune
- Ahmedabad
- Chennai
- Remote global teams
Typical career progression
- 1
Entry
RA Associate · Clinical Affairs Associate
- 2
2–4 years
CER Writer · RA / Clinical Specialist
- 3
4–7 years
Senior Clinical Evaluation Specialist · RA Lead
- 4
Leadership
Head of Regulatory / Clinical Affairs
Student proof
Medical device regulatory course reviews, placements and student stories
4.6
BCRI is rated 4.6/5 from 987 Google reviews (as of Oct 2026)
Recent BCRI placements & internships
Is this course right for you?
Talk to a BCRI advisor about eligibility, batches, fees and career paths. It’s free and there’s no obligation.
FAQs
Medical Device Regulatory Affairs — frequently asked questions
What is a medical device regulatory affairs course?
It teaches the rules a medical device must meet to reach patients and stay on the market: classification, clinical investigations under ISO 14155, clinical evaluation reports, approvals and post-market surveillance. This course covers EU MDR in depth, plus India’s CDSCO and the US FDA.
What is ISO 14155?
ISO 14155 is the international standard for Good Clinical Practice in clinical investigations of medical devices on people. It sets out how to design, run, record and report a device study, and the duties of the sponsor, investigator and monitor. The current edition is ISO 14155:2020.
How is device GCP different from ICH GCP?
ICH GCP is written for medicines. ISO 14155 is written for devices, so it adds device-specific topics such as device deficiencies, the Clinical Investigation Plan and the link to risk management (ISO 14971). Many people in device studies need both.
What is a Clinical Evaluation Report (CER)?
A CER is the document that shows, with clinical data, that a device is safe and performs as intended. Under EU MDR every device needs one. It is based on a Clinical Evaluation Plan, uses literature, clinical investigation and post-market data, and is updated throughout the device’s life.
Who can join this course?
Anyone with basic clinical research knowledge and a degree in life sciences, pharmacy, biomedical science, biotechnology, medicine, nursing or engineering (biomedical, electronics, mechanical) can join. It also suits clinical research and regulatory professionals moving into medical devices.
Do I need to know clinical research first?
Yes. Basic knowledge of clinical research is required, because the course builds on it for devices. If you are new to the field, start with the CRA Training Program or the PG Diploma in Clinical Research.
What is the duration and mode of the course?
The course is 40 hours of live online classes, with recordings and notes for revision.
What are the fees?
The course fee is ₹28,000 (list price ₹35,000). Paying the full fee online when you apply gives 5% off, and instalments are available.
Does this course cover drug regulatory affairs too?
No. This course covers medical devices only. For drug-safety regulations, see the Certification in Advanced Regulatory Affairs.
Can I join from outside India?
Yes. The course is live online, so you can join from anywhere. EU MDR and FDA topics are useful for device roles in Europe, the US and global teams. Ask an advisor about batch timings for your time zone.
Does BCRI provide placement support?
Yes. Our placement team helps with resumes, mock interviews and job referrals. The employer makes the final hiring decision, so a job is not guaranteed.