ISO 13485 Medical Devices Training

#ISO13485Training #MedicalDevicesCareerdevelopment #Pharmaceutical #Pharmadomain

ISO 13485 QMS Standards – is a Quality management standard used globally for medical devices. It is used to establish and update your organization’s Quality Management System (QMS). 
ISO is a process standard for medical devices, it generally help organizations achieve standards of process quality that are recognized and respected throughout the world.

Some of the requirements in ISO 13485 Standards include a set of procedures that cover all key processes in the business; monitoring processes to ensure they are effective; keeping adequate records; checking output for defects, with appropriate and corrective action where necessary; regularly reviewing individual processes and the quality system itself for effectiveness; and facilitating continual improvement for medical devices.

Features & benefits of ISO 13485 are as follows : 

  • Determine the needs and expectations of customers
  • Determine the capability of process for customers, as per basic processes for ISO 13485 standard
  • Establish policies, objectives and standardized system for Medical Devicest
  • Necessary to motivate people to satisfy these needs
  • Design, implement and manage a Medical Devices organizational system of inter-related processes to implement the policy and attain the objectives
  • Pursue the continual improvement of the system from an objective evaluation of its performance

For Consulting and Implementation Assignments :

  • VQMS conducts pre-analysis – Gaps analysis towards ISO 13485 Medical Devices based management SYSTEM in your organization
  • provides actual plan related to consulting – implementation – Audit Management
  • Executes the plan, been finalized by the client or management.
  • Appx. man days invested will be 8-10, for min 2-4 processes

Interested Participants or Audiences ?

VQMS specifically designed program, meets the requirements of the following: 
  • Leader of projects in HR/Admin/ Management team of Organizations
  • Managers or Future managers including management students
  • Fresh or exp engineering graduates / MBA’s / Professionals / Job seekers.
  • Quality Assurance Engineers, Team leaders, IT or Non-IT Professionals, Practitioners, Software Quality Assurance team members and Jr /Senior Management
  • Any other professional members who are doing research, innovations or consulting in process improvement practices

Post Completion of the course :

  • Assisting in improving interview skills vis-a-vis six sigma & Quality (Business excellence)
  • Provide exclusive counselling in other areas of improvement.
  • VQMS assist in professional resume preparation

For any query please mail at [email protected]

Please enable JavaScript in your browser to complete this form.