DKNSB Medical Device Consultant Launches Two Day Training Course for Risk Management ISO 14971

Risk Management Training for Medical Device Professionals

Beneficial for
-Professionals involved in risk assessment and management
-QA and QC Professional
-Professionals involved in designing development and manufacturing
-Medical Device Design Engineers
-Product Managers
-Regulatory Affairs Professionals

Course Outline
Risk Management is an important and complex process that is growing in importance for medical device companies with its introduction into a number of recently published medical device standards. ISO 14971 has been written to enable its integration into existing company quality systems and provides a disciplined approach for proactive decision making based on recognised risk and the implementation of strategies to mitigate those risks. This practical, workshop based course with case studies has been designed to provide delegates with the skill (including tools and techniques) and knowledge required to understand, interpret and apply ISO 14971 as well as the ability to integrate risk management into their existing organisation and Quality Management Systems.

The course will focus specifically on the ISO 14971 requirements in relation to the development and implementation of an effective risk management lifecycle and will also incorporate the requirements of the Global Harmonization Task Force’s guidelines.

Main Points:
-Requirements for risk management
-Overview of ISO 1497 Standard
-Risk Management process
-Risk management file
-Risk management plan
-Suitable format for Risk Management report
-Risk Analysis Process
-Identification of Hazard
-Risk Evaluation – Identification of harms, hazards and hazardous situations, tools and techniques including FMEA, Fault Tree Analysis
-Risk Reduction and Control
-Estimation of Residual Risk
-Risk Report including the risk benefit analysis
-Production and Post Production requirements as part of ongoing Post Market Surveillance activities
-Relation with the other medical device standards
-Overall Risk Management throughout the product lifecycle
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Medical Device Registration In India

We are the group of experienced and energetic health care professionals, regulatory compliance consultants and doctors. We serve many segment of Medical device industry with emphasis on Orthopedic Implant, Internal Prosthesis Replacements, Disposable Hypodermic Syringes, Disposable Hypodermic Needles, Disposable Perfusion Sets, Cardiac Stents, Drug Eluting Stents, Catheters, Intra ocular Lances, I.V. Cannulae, Heart Valves and Bone Grafts/Bone Cements.
We serves only for medical device industry and offer a wide range of services that includes
  1. Medical Device Factory Layout Planning and factory setup service.
  2. Manufacturing Licensing consultancy service (In form 28).
  3. Import Licensing consultancy service (In form 10).
  4. Consultancy for medical device registration and approval in India (In form 41).
  5. Quality Systems Implementation service.
  6. ISO 13485 and CE Certification consultancy service.
  7. Audit preparation, Document preparation and Quality management system Training.
  8. Clinical Evaluation and Risk Management.
  9. US FDA 510(k) Consulting for Medical Devices.
  10. Consultancy for Medical Device Registration in India.
  11. Indian authorized agent for medical device companies.
Based in New Delhi, we assist domestic firms throughout the INDIA, as well as international clients mainly in Asia (China), USA and Europe.
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