Certificate in Quality Management System for Medical Devices (ISO 13485)

Certificate in Quality Management System for Medical Devices (ISO 13485)

As a prevalent leader in professional training, we offer outstanding training and professional guidance in Quality Management System (Medical Devices) which aids you to excel in your field and meet up with your exact requirement. The training programmes of IGMPI do not only focus on the theory but also give you the insight of real world. The coverage of programme also includes the present day scenario of suppliers’ control and detail outlook to be considered in the: “Own Branding” and “Own labeling”. The students will also gain benefits from training by getting knowledge about the risk management system associated with outsourcing and supplier control.

This training is specially framed for providing the students with important qualities for performing internal audits on a company’s Quality management systems for Medical devices for the requirements of ISO 13485:2016 and to be responsible for overall development. This also covers the process of gaining CE marking certification under updated EU and USA regulations for all the medical devices which include: total joint implants and drug device combinations and associated directives. The certification programme also includes the review of technical document and site audits. The site audits will majorly analyze compliance with both ISO 13485:2003 and updated EU directives. This training programme has been designed to indicate all the changes in regulatory front so that the manufacturer of the medical device can better understand the intricacies of updated EU IVDR and covers in vitro diagnostic medical devices and the requirement mentioned in it are for the manufacturers, Notified bodies and member state component authorities.

This training is going to assist your organization at compliance engineer, quality professional, training auditor and general levels. It helps in understanding of how the new regulatory norms are going to affect business, In addition is also guides consultant and the customer to write and revise the quality documents and consolidate technical files and provide guidance on quality and regulatory department. This programme is going to guide you to head out for intricacies while making sure that the compliance with required regulations are met with top level of safety to patients and healthcare professional.

Programme Modules

Module 1: In depth knowledge of effectiveness of Quality Management System.

Module 2: Overview of new regulations.

Module 3: Practical application of USA, European Union and Indian medical device regulations.

Module 4: Requirement of USA, European Union and Indian CE marking of medical devices

Module 5: Requirement of USA, European Union and Indian marking of in vitro diagnostic medical devices

Module 6: Technical documentation for Medical Device compliance in USA, European Union and India

Module 7: Understand the requirement of ISO 13485:2016 -quality system requirement

Module 8: Understand how to conduct internal audits

Module 9: Detailed knowledge of ISO 13485:2016 audit and certification process

Module 10: Develop knowledge and skills to prepare for third party audits against the requirement of ISO 13485:2016

Module 11: Better understanding of internal audits, audits of supplier and third party audits of medical devices manufacturers.

Eligibility

Any graduation/ B.tech/ B.Sc. in Microbiology/ Life Sciences/ Botany/ Zoology/ Food Science/ Food Technology/ BE/ B.Pharma/ MBBS/ BDS/ BHMS/ BUMS/ BAMS or any other discipline. Diploma holders are eligible for our Executive Diploma, Industry Certificate, and Certificate Programmes.

Programme Duration

Minimum duration to complete this programme is 3 months and maximum is 6 months.

Registration

The registration dates for this programme run by the Institute are updated timely on the webpage. Effective Online learning tools incorporated into the design of the webpage make the programme lectures, online live classes and study material easily accessible. This gives a huge window of self-regulated and self-paced performance to the participants.

Programme Deliverables

A comprehensive study material for all the modules in hard copies ensuring the needs of the audience. The accompanying training material is appropriately aligned with the current Industry’s expectations.

– Interactive or online live sessions on all key areas of the programme giving all flexibility to the participants.
– Online classes for all the modules will be conducted on the weekends. Moreover, a doubt clearing session will also be scheduled before the examination.
– All the efforts are made by IGMPI faculty members to make the entire programme modules easily understandable.
– Assessment and evaluation for all the programme modules in order to enhance the levels of competencies and skills of the participants leading towards the objective of application in the job.
– At the end of each programme modules, the trainers shall obtain feedback from the participants using specially designed questionnaires.
– All learning and training delivery initiatives shall be conducted in English.

Examination & Certification

IGMPI follows a credit system based on all learning activities involved in studying for all PG Diploma, Executive Diploma and Certificate Programmes. Each of your modules is equal to 4 credits. To successfully complete the programme, you will have to earn all the credits assigned to your programme.

All the participants are expected to appear for online exam and are also obliged to submit assignments after each module. After successful completion the participants will be awarded Certificate in Quality Management System for Medical Devices by IGMPI. For all the above mentioned modules elaborate programme material, assignment and case studies would be provided by the Institute from time to time. Details get updated on the webpage as well.

Placement Assistance & Corporate Relations

The Institute has partnered with many organizations for providing with placement assistance to in its participants. Besides, it has a robust placement cell comprised of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. This cell is continuously engaged in promoting the employability of our participants and encouraging the concerned Human Resources department and Hiring Managers to recruit/hire our participants for their vacant positions. The efforts of our placement cell also include helping with professional resume writing & interview skills.

In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical, healthcare like Dr. Reddy's Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, IPCA Laboratories, Calyx, Bliss GVS Pharma, SeQuent, Mankind, Beryl Drugs, Allergy Therapeutics, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Ranbaxy , Biocon etc. The IGMPI's Corporate Resource Division actively recommends our students and training participants for various job requirements and specialized roles to Human Resource, Talent Acquisition as well as the heads of various departments in Pharmaceutical, Healthcare industries on regular basis.

Future career prospects of Certificate in Quality Management System (Medical Devices)

Certificate in medical device will provide a horizon of knowledge to support you and your organization in the path of success. It will help you understand every step of assessment and procedures so that you fully understand the subject and standards that are applied across the whole supply chain and seeks to address he entire life cycle of Medical device.

View Prospectus

Programme Fee Details

How to apply

For further enquiries, write to or call us on:
info@igmpi.ac.in / 18001031071 (Toll Free), Phone: +91 11 26512850