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Home /Regular Professional Certification Courses/ Medical Device Quality Assurance

Medical Device Quality Assurance

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Eligibility:

  • Diploma in biomedical / medical electronics/ electrical/any other related field. B.E/ B. Tech in Biomedical Engineering, Biomedical Instrumentation Engineering/ Medical Electronics/ any other related field. All those who have completed their Graduation or post graduation in life science/ Pharma/ PhD are eligible to enroll for the courage. QA/QC, Production, Managers and Staff working in Medical Device industry.Regulatory affairs, R&D staff in Medical Devices.

Course Description

This course will cover Definition and Classification, Overview of global medical device industry, Medical device design process, MEDICAL DEVICE REGULATION IN USA, EU, Canada, India, Australia, Japan, China, Middle East, Technical file documentation, Quality management system-ISO13485:2016, risk management system-ISO 14971:2019, clinical and safety testing, MDSAP.

Internal Auditor/Lead Auditor QMS 13485-2016, ISO 19011-2018 Course

Eligibility:

  • Diploma in biomedical / medical electronics/ electrical/any other related field. B.E/ B. Tech in Biomedical Engineering, Biomedical Instrumentation Engineering/ Medical Electronics/ any other related field. All those who have completed their Graduation or post graduation in life science/ Pharma/ PhD are eligible to enroll for the courage. QA/QC, Production, Managers and Staff working in Medical Device industry. Regulatory affairs, R&D staff in Medical Devices.

Course Description

This course will cover Introduction to ISO 13485, Skills required by an auditor, how to audit using the process approach, Identify and document nonconformities, ISO 13485 Medical Devices Quality Management Systems, Provide critical knowledge for your management staff, Gain insight into the ISO 13485 audit requirements to augment/sustain your existing program.

Indian MDR 2017 Rule, BIS, ISI Mark along with Sugam Online Submission

Eligibility:

  • Diploma in biomedical / medical electronics/ electrical/any other related field. B.E/ B. Tech in Biomedical Engineering, Biomedical Instrumentation Engineering/ Medical Electronics/ any other related field. All those who have completed their Graduation or post graduation in life science/ Pharma/ PhD are eligible to enroll for the courage. QA/QC, Production, Managers and Staff working in Medical Device industry. Regulatory affairs, R&D staff in Medical Devices.

Course Description

This module will cover New Indian Medical Device Regulation-MDR 2017, BIS Submission, Sugam Portal Submission.

Medical Device-European MDR, CE Mark

Eligibility:

  • Diploma in biomedical / medical electronics/ electrical/any other related field. B.E/ B. Tech in Biomedical Engineering, Biomedical Instrumentation Engineering/ Medical Electronics/ any other related field. All those who have completed their Graduation or post graduation in life science/ Pharma/ PhD are eligible to enroll for the courage. QA/QC, Production, Managers and Staff working in Medical Device industry. Regulatory affairs, R&D staff in Medical Devices.

Course Description

This module covers New regulations, Timeline line and transition of new regulations, Key aspects of new regulations, Classifications, Registration, Notified body designation, CE Marks.

Medical Device- USFDA Submission

Eligibility:

  • Diploma in biomedical / medical electronics/ electrical/any other related field. B.E/ B. Tech in Biomedical Engineering, Biomedical Instrumentation Engineering/ Medical Electronics/ any other related field. All those who have completed their Graduation or post graduation in life science/ Pharma/ PhD are eligible to enroll for the courage. QA/QC, Production, Managers and Staff working in Medical Device industry. Regulatory affairs, R&D staff in Medical Devices.

Course Description

This module will cover Establishment of regulation and device listing, Premarket notification-510(k), Premarket approval, Investigational device exemption, Labeling requirement, Medical device reporting.

MDD to MDR Implementation

Eligibility:

  • Diploma in biomedical / medical electronics/ electrical/any other related field.B.E/ B. Tech in Biomedical Engineering, Biomedical Instrumentation Engineering/ Medical Electronics/ any other related field. All those who have completed their Graduation or post graduation in life science/ Pharma/ PhD are eligible to enroll for the courage. QA/QC, Production, Managers and Staff working in Medical Device industry. Regulatory affairs, R&D staff in Medical Devices.

Course Description

This module will cover Difference and similarities between MDD and MDR, MDR Transition period, key aspect of new regulations, new regulatory process.

Medical Device-Risk Management

Eligibility:

  • Diploma in biomedical / medical electronics/ electrical/any other related field. B.E/ B. Tech in Biomedical Engineering, Biomedical Instrumentation Engineering/ Medical Electronics/ any other related field. All those who have completed their Graduation or post graduation in life science/ Pharma/ PhD are eligible to enroll for the courage. QA/QC, Production, Managers and Staff working in Medical Device industry. Regulatory affairs, R&D staff in Medical Devices.

Course Description

This module will cover Risk Management (ISO 14971) in the development and use of medical devices. Standards, regulations methods, and tools for identifying, analyzing, and controlling risks, Risks and hazards associated with the system and its use so that we can reduce the probability of its harm to people and environment by using Risk analysis., Risk analysis using the harmonized standards according to your medical device.

Implementation of MDSAP

Eligibility:

  • Diploma in biomedical / medical electronics/ electrical/any other related field. B.E/ B. Tech in Biomedical Engineering, Biomedical Instrumentation Engineering/ Medical Electronics/ any other related field. All those who have completed their Graduation or post graduation in life science/ Pharma/ PhD are eligible to enroll for the courage. QA/QC, Production, Managers and Staff working in Medical Device industry. Regulatory affairs, R&D staff in Medical Devices.

Course Description

This module will cover Fundamentals of MDSAP, Origin and Objective, Key terms and Definitions, How does MDSAP works?, What are the MDSAP requirements?, Supporting documents for MDSAP, MDSAP Audit Cycle.