ISO 13485 Awareness Training

Introduction to ISO 13485 Awareness Training in India

ISO 13485 Awareness Training in IndiaInzinc Training Solutions conducts ISO 13485 awareness Training in India. This training helps an individual and an Organization to learn the basics of the ISO 13485:2016 Quality Management System for Medical Devices (QMS-MD) Standard before implementing it. By registering to this training, professionals will learn the basics of Quality Management System as per the ISO 13485:2016 Standard. This training is available to you through online as well as on-premise training modes as per the convenience of our Customers.

Learning objectives of the ISO 13485 Awareness training

The ISO 13485 Awareness Training is conducted with the below learning objectives to achieve after the training session:

  • Understanding the basics of Quality Management System – Medical Devices and ISO
  • Learn briefly the ISO 13485:2016 Clauses 
  • Learn the benefits of implementing the Quality Management System for Medical Devices

Audience for the ISO 13485 Awareness Training

The right audience to take the ISO 13485 Awareness training are:

  • Management Representative who is nominated for the implementation of ISO 13485 Standard in their Organization
  • Process Owners or Departmental Heads of the Organisation
  • Top Management
  • Employees

Brief topics covered in the ISO 13485 Awareness training

The topics that are covered in the ISO 13485 Awareness Training session are as below:

  • Basic Quality definitions and concepts (Quality, Quality control, Quality assurance, Quality Management, etc.)
  • What is a Quality Management System ?
  • Basic introduction to Medical Devices
  • What is ISO ? What is its brief history ? 
  • What is ISO 13485 ?
  • Benefits of ISO 13485 standard implementation
  • The PDCA Cycle
  • Briefly understand each clause of ISO 13485:2016 standard.

Highlights of the Course

  • Classroom learning
  • Examples wherever relevant
  • Case studies
  • Exercises

Duration of the training

The duration of training is 2 days with minimum of 14 hours of training

Mode of the training

We conduct training through two modes:

  • On-premise training at our Customer’s premises or our training centers
  • Remote online training with live Presentation through video-conferencing

Faculty for the training

Experienced tutor with Industry and auditing experience who is also an ISO 13485 Auditor

Trainee Evaluation

Trainees will be given a simple test on the training topics. These may be mostly objective based with few descriptive questions. 

Evaluation and Certification

Candidates will be awarded soft copy certificates within 1 working day after the course subjected to passing the test on training topics. Hard copies will be couriered post training session within a working week. This is subject to Force Majeure / other emergency conditions.

Study Material

Candidates will be provided with hard copy slide notes on the above topic. For trainees enrolled into the online training mode, we will provide them with the soft copy slide notes for their reference.

Fill up the training registration form below and submit the details to enable us to provide you with an offer.

Pre-requisite for training

Though we put our best efforts to train personnel in limited time, as a pre-requisite it helps trainees immensely if they have glanced through the ISO 13485 standard at least once before attending the training session. By this, their level of correlating and understanding the concepts and clauses is enhanced.


Training Registration Form

Online ISO 13485 Awareness Training in India

Besides On-premise training, Inzinc Training Solutions conducts Online ISO 13485 awareness training in Bangalore (Bengaluru) and other places like Bagalkot, Belgaum (Belagavi), Bellary, Bidar, Bijapur, Chamarajanagar, Chikmagalur, Chitradurga, Coorg, Dakshina Kannada, Davanagere, Dharwad, Gadag, Gulbarga, Hassan, Haveri, Honnavar, Hospet, Hubli (Hubballi), Kolar, Koppal, Mandya, Mangalore (Mangaluru), Manipal, Mysore, Nanjangud, Raichur, Ramanagaram, Ranibennur (Ranebennuru), Shimoga (Shivamogga), Tiptur, Tumkur, Udupi, Uttara Kannada, Yadgir, and other cities in Karnataka.

Inzinc Training Solutions also conducts Online ISO 13485 awareness training in India cities including Chennai, Coimbatore, Hyderabad, Amravati, Vizag, Vishakapatnam, Trivandrum (Thiruvananthapuram), Kochi, Panjim (Goa), Pune, Mumbai, Nashik, Gandhinagar, Vadodara (Baroda), Ahmedabad, Jaipur, Johpur, Chandigarh, Delhi, Kolkata, Bhopal, Baddi, Gurugram (Gurgaon), Noida, Gwalior, Indore, Haridwar, Dehradun, Jamshedpur, Durgapur, Bhubaneswar, Raipur and other cities in India.

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