Training is teaching, or developing in oneself or others, any skills and knowledge that relate to specific useful competencies. Training has specific goals of improving one’s capability, capacity, productivity and performance. In Meditix we are focusing on conducting Regulatory, QMS and Clinical Trainings as per the Client’s requirement.
ISO 13485: International Quality Management Standard for Medical Devices
ISO 13485 is an international management standard developed specifically for medical device manufacturers. It provides a harmonized model for creating and maintaining an effective quality management system (QMS) for the design and manufacture of medical devices. This training provides you with an overview of the purpose and requirements of ISO 13485 and how to improve customer relationships, operations and corporate culture by the effective use of a QMS.
The training is an introduction for anyone involved in the development, implementation and management of a QMS based on ISO 13485. Upon completing the training, you will be able to interpret all clauses of ISO 13485:2016 and recognize the role of management in implementing and maintaining ISO 13485.
The course comprises lecture and workshop exercises.
Contact Meditix today to learn more about ISO 13485 Awareness Training.
Applied ISO14971 Medical Device Risk Management
The internationally accepted standard guideline for medical device risk management is the ISO 14971 standard.
Meditix’s training is designed to provide a concise but complete knowledge of medical device risk management to supplement readings of the 80-page standard and to initiate those who are new to the medical device industry.
Our focus has been given to explaining the use of key tools such as the Failure Mode and Effects Analysis (FMEA) and the Fault-Tree Analysis (FTA) to enable immediate application in ISO 14971 projects.
This training offers a systematic methodology to comprehend medical device risk management and connects the vital elements of risk management methodologies for a more efficient application of principles.
This training also provides guidelines on how to conduct productive meetings to construct medical device risk profiles.
Our Clinical team delivers clinical trainings on conducting clinical trials, clinical evaluation and conducting Post Market Clinical Follow up studies.
Our curriculum can deliver training on
Clinical Validation of the New Medical Devices
Clinical investigation of medical devices for human subjects – Good Clinical Practice – ISO 14155: 2011
Clinical Evaluation Process – MEDDEV 2.7.1. Rev.4 – Clinical Evaluation – A guide for manufacturers and notified bodies under directives 93/42/EEC and 90/385/EEC.
Post Market Clinical Follow up Study – A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES, MEDDEV 2.12/2 rev2
We deliver training to Medical Device Manufacturers for meeting the knowledge on Product compliance and testing.
The compliance trainings we can deliver are listed below:
IEC 62304:2006 : Medical device software — Software life cycle processes
IEC 62366-1:2015 : Medical devices — Part 1: Application of usability engineering to medical devices
IEC Collateral and Particular Standards.