The document presents ISO 13485:2016, which outlines quality management system requirements for medical devices to ensure consistent customer satisfaction and regulatory compliance. It highlights the differences from ISO 9001, emphasizing effective implementation over continual improvement and specifics on risk management, documentation, and traceability. The certification process involves multiple phases to ensure thorough preparation and support for organizations seeking compliance.

1. Medical Devices - Quality management system
Presentation By: M.Rajashekhara Gowda
Process Improvement specialist
Veave Technologies

2. What is ISO 13485 : 2016 ?
Medical devices -- Quality management systems
Requirements for regulatory purposes.
where an organization needs to demonstrate its
ability to provide medical devices and related
services that consistently meet customer and
applicable regulatory requirements.

3.  Organizations can be involved in one or
more stages of the life-cycle, including
design and development, production,
storage and distribution, installation, or
servicing of a medical device and design
and development or provision of
associated activities .

4. Reason for use ….!
 While it remains a stand-alone document,
ISO 13485 is generally harmonized with ISO
9001.
 A principal difference, however, is that ISO
9001 requires the organization to
demonstrate continual improvement,
 whereas ISO 13485 requires only that the
certified organization demonstrate the quality
system is effectively implemented and
maintained.
 Additionally, the ISO 9001 requirements
regarding customer satisfaction are absent
from the medical device standard.

5. Benefits to your Company ..
 The promotion and awareness of regulatory
requirements as a management
responsibility
 Controls in the work environment to ensure
product safety
 Focus on risk management activities
and design control activities during product
development
 Specific requirements for inspection and
traceability for implantable devices.
 Specific requirements for documentation
and validation of processes for sterile
medical devices.

6. Certification process
Phase 1
• An initial discussion about existing practices to
evaluate.
Phase 2
• A complete gap analysis of your company with respect
to your certification requirement.
Phase 3
• A custom written mandatory certification
documentation, training and complete pre-assessment.
Phase 4
• Certification audit by certification body - guaranteed
success !

7. Why choose us ?
We make Entire process hassle - free for the
client.
Industry experts.
Well documentation.
Fast turnaround.
Excellent support.
Affordable price.
Post certification services.
Total customer satisfaction.