TRAINING

WHY IS TRAINING REQUIRED IN THE ORGANIZATION?

Training presents a prime opportunity to expand the knowledge base of all employees which contributes to the increased output per employee as well as overall growth of the Organization. There are certain temporary immediate drawbacks observed by training felt by some employers like - many employers find the development opportunities expensive, employees also miss out on work time while attending training sessions, which may delay the completion of projects.

However, despite the potential drawbacks, training and development provides both, The Organization and the Employees, with benefits that make the cost and time a worthwhile investment due to following benefits:

  • Requirement by Regulatory and other Authorities.
  • Understanding the applicability of industry-specific Regulatory requirements and ensuring compliances.
  • Continued Maintenance of the Applicable Statutory and Regulatory requirements
  • Identifying the area of improvement of employee and upgrading through trainings.
  • Improvement in employee’s performance.
  • Consistency in duty performance.
  • Ensuring worker satisfaction.
  • Increased Productivity.
  • Improved quality of services and products.
  • Reduced cost.
  • Reduction in supervision.

TYPES OF TRAINING PROGRAMS OFFERED:

MDC Provides customized training solutions for the Medical Device Industry.

The training can be provided on site or in classroom.

Each of the training modules is designed carefully to take care of the understanding of the standards/guidelines part as well as includes well-designed practical exercises based on industry-specific issues. This gives an insight of the actual expectation from the standards/guidelines as well as interpretation of the same for correct and effective implementation in the routine tasks performed.

Some of Our Specialized training modules are as below:

Sr. No.

Standard / Regulation

Transitions

1

ISO 9001:2008

ISO 9001:2015

2

EN ISO 13485:2012

ISO 13485:2016

3

ICMED 9000

N.A

4

ICMED 13485

N.A

5

MDR 2017 Schedule –V

N.A

6

Directive(93/42/EEC)

MDR 2017-745. Medical devices

7

In-vitro diagnostic medical devices (Directive 98/79/EC)

IVDR 2017-746 In-vitro diagnostic medical devices

8

ISO 14001 :2004

ISO 14001 :2015

9

OHSAS 18001:2007

N.A

10

Clinical Evaluation Meddev 2.7.1 Rev. 4

11

Risk Analysis EN ISO 14971:2012

 

12

Regulatory Orientation (Medical Devices)

 

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