ISO 13485 Consulting for medical device manufacturers. Get regulatory guidance from the expert. ISO 13485 Certification.

1. ISO 13485
CONSULTANT ISO
13485 CERTIFICATION
FOR MEDICAL DEVICE
https://www.operonstrategist.com/iso-15378-
quality-assurance/

2. ISO 13485 CERTIFICATION: QUALITY MANAGEMENT
SYSTEM FOR MEDICAL DEVICE INDUSTRIES
ISO 13485 Certification for Medical devices is a quality
management system required for regulatory purposes which is an
ISO standard, it was published for the first time in 1996, that
represents the requirements for a comprehensive quality
management system for the design and manufacturing of medical
devices. This standard replaces earlier documents such as EN
46001 and EN 46002 (both 1997), the previously published
standard were ISO 13485 (1996 and 2003), and ISO 13488 (also
1996).

3. The latest ISO 13485:2016
specifies requirements for a
quality management system
where an organization
needs to demonstrate its
ability to provide medical
devices and related services
that consistently meet
customer and applicable
regulatory requirements.

4. Such organizations can be involved
in one or more stages of the life-
cycle, including design &
development, production, storage,
distribution, installation, servicing
of a medical device or provision of
associated activities (e.g. technical
support). The standard provides an
effective framework to meet the
comprehensive requirements for a
medical devices quality
management system.

5. ISO 13485 STANDARD BENEFITS:
 Increase access to more markets worldwide with
certification.
 Outline how to review and improve processes across your
organization.
 Increase efficiency, cut costs and monitor supply chain
performance.
 Demonstrate that you produce safer and more effective
medical devices.
 Meet regulatory requirements and customer expectations.

6. Operon Strategist is ISO 13485 consultant helps to create the
documents for ISO 13485 certification. In the first phase, Our
special screen sharing module helps the client to create that
documentation and provide adequate training. This includes
the creation of the SOP,s work instructions, Quality Manuals,
VMP’s, Process Validation documentation etc. In the second
phase, we provide assistance to implement the system at
Shop Floor and provide the need-based training to make
that the system is adequately implemented. On a routine
basis, we monitor the system including the Management
review meetings, Internal quality audits, Customer
Complaints, CAPA Management, Handling of Non
confirming Products etc. We assist to maintain the complaint
system and continual preparedness for the audits.

7. Thank You.
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