Admission Open

Certificate in Biomedical Quality Assurance

(NSDA Approved Course; Job Role No: 2019/HLT/AMTZ/3578)

Last date for Registration 25th August 2020 – 5:00 PM (IST)

Step 1: Pay the Fee to the given bank account via NEFT/RGTS

Bank Details:
Name of the account holder: ANDHRA PRADESH MEDTECH ZONE
Account Number: 036505005004
Bank Name: ICICI Bank
IFSC Code: ICIC0004362
Swift Code: ICICINBBCTS

Step 2: Fill the Google Form  

Google Form Link 

 

Program Objective:

The objective of this training program is to develop a pool of workforce which can be employed by focuses on the acquisition of skills necessary to develop quality control of medical devices and validation process.

As per the training modules at the end of the training, the candidate would be certified to perform following activities –

a) Works cooperatively with R&D, Process Development, Quality, Production, Regulatory, Equipment Engineering, Supply Chain, and Marketing to ensure project success.

b) Prepares standard reports/ documentation to communicate results to the technical community.

c) Responsible for developing appropriate test methods and inspection plans. Test methods shall be validated as necessary.

d) Ensures quality products are developed in accordance to governing regulations and processes.

e) Actively participate and assist teams with Risk Analysis to include Risk Assessments.

f) Responsible for product change assessments, health hazard evaluations and product recall documentation.

Eligibility:

i) For Diploma candidates: Diploma in Biomedical Engineering, Biomedical Instrumentation Engineering / Medical Electronics / any other related field, with 3 years of experience in biomedical field.

ii) For Engineers: B. E / B. Tech in Biomedical Engineering, Biomedical Instrumentation Engineering / Medical Electronics / any other related field, with 2 years of experience in biomedical field.

Modules:

1) Medical Device Quality and Regulatory Fundamentals

2) Risk Management & Risk Analysis

3) Medical Technology Quality Systems

4) Design Control & Product Development

5) Design verification, Validation, clinical evaluation and CAPA

To see the thematic areas of modules click here

Duration:

3 Months (50 Hours – Online Lectures by Industry Experts – Weekends)

Course Fee:

Indian Nationals: INR 15,000/- (including GST).
Foreign Nationals: USD

Assessment Fee:

Indian Nationals: INR 900 per module (total INR 4,500/- for 5 Modules)
Foreign Nationals: USD 25 per modules (total USD 125 for 5 Modules)

Downloads

Qualification Pack

Model curriculum