Certificate in Biomedical Quality Assurance
(NSDA Approved Course; Job Role No: 2019/HLT/AMTZ/3578)
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.
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.
- Medical Device Quality and Regulatory Fundamentals
- Risk Management & Risk Analysis
- Medical Technology Quality Systems
- Design Control & Product Development
- Design verification, Validation, clinical evaluation and CAPA
To see the thematic areas of modules click here
Note: If candidate has qualified in any module, he /she can take assessment in new modules and get “Skill Certificate Approved by NSDA”.
The “Certificate in Biomedical Quality Assurance” program designed for mid-level professionals of “Quality Assurance / Quality Control”. Quality professionals ensure that the products meet the highest possible levels of quality, safety and consistency. These professionals are responsible for maintain guidelines – particularly GMP (Good Manufacturing Practice), ISO 13485 and ISO 9000. Career paths in Quality can take them in many different directions as they develop expertise in technologies, systems, products and processes.