ACTIVE MEDICAL DEVICES
IMPLANT MEDICAL DEVICES
DISPOSABLE MEDICAL DEVICES
SOFTWARE MEDICAL DEVICES
IVD MEDICAL DEVICES

ISO 13485 Consultants role in Implementation

Medical Device Quality Management System or ISO 13485:2016 or EN ISO 13485:2016 must be implemented for the regulatory purpose by all dealing with the Manufacturing, Designing, Distribution, Servicing, Testing and Sterilization.

Role of ISO 13485 Consultants is crucial as the Implementation is mainly for the regulatory purpose.


European Medical Device Directive or New Medical Device Regulation for CE Marking mandates for EN ISO 13485:2016 by way of latest Harmonized Standards.

EN ISO 13485:2016 Consultants is important at this moment. I would like to take your attention; the ISO Consultant and medical device regulatory consultant are different. Always an experienced ISO 13485 Consultants can deliver proper technical and scientific information.

If you are a just a distributor and not planning to affix CE Marking you can appoint a QMS /ISO consultant, but when you are planning for CE Marking your medical device, EN ISO 13485:2016 implementation is a must and should be designed in line with MDD / MDR requirements.

Therefore manufactures planning for CE Marking or FDA clearances must appoint regulatory consultants with experience in EN ISO 13485:2016 implementation.


The general EN ISO 13485:2016 requirements for compliance includes many mandatory procedures and record types in order to be implemented and certified, all of which must be reviewed, approved, maintained and updated to remain in compliance.

I 3 CONSULTING specialize in document drafting, training, supporting, review and Internal auditing for all manufacturing and related services to ensure full compliance to the EN ISO 13485:2016 standard.

In addition, I 3 CONSULTING can create paper systems, electronic systems, or even web-based documentation control system which may be accessed from anywhere in the world and can be tailored to your organizational structure and requirements.

The role of EN ISO 13485:2016 is of great importance as the standard revised and was published on 1 March 2016. IAF Resolution 2015-13 details a transition period of three years from the date of publication.

We, ISO 13485 consultants, focus mainly on medical device and IVD companies, so we understand the unique needs and manufacturing scenarios of the industry. Our ISO 13485 consultants are EN ISO 13485:2016 lead auditors and approved internal auditors.

Our team of ISO 13485 consultants customize your ISO 13485 quality system to meet your organizational specific needs and make sure you are ready for ISO 13485 certification audit from a Certification Body.


Our ISO 13485 consulting is very economic as the majority of the activities are carried out offline. Few more benefits are listed below:

  • 1. Qualified and experienced medical device ISO 13485 consultants
  • 2. EN ISO 13485:2016 Consultants are certified Lead Auditors
  • 3. Largest fool of full time ISO 13485 consultants
  • 4. Largest reference standard and document collection
  • 5. Offsite (online) ISO 13485 consultancy with very normal fee
  • 6. Payments based on deliverables.
  • 7. Good reputation with all Certifying bodies.

(EN) ISO 13485:2016 Implementation and Certification timeline


Post appointing I 3 CONSULTING it takes approximately 4 weeks for drafting the documentation and additional 4 to 6 weeks for implementation in a mid-sized organization with 30 employees. Larger firms with more than 50 employees and/or multiple locations require more time. The timeframe for certification is also dependent upon the availability of Certification Body and there approved auditors to audit and certify your company.

The cost of Consultancy and Implementation click here

Need More Information About (EN)ISO 13485:2016 consultation

Write to us at enquiry@i3cglobal.com for quick answer across the globe.

INDIA -Bangalore
+ 91 994 591 2081
Phone / WhatsApp


USA -Chicago
+1 630 696 1293
Phone / WhatsApp


GERMANY-Bremen
+49 2161 990 8831
Phone / WhatsApp

enquiry@i3cglobal.com

LiveZilla Live Chat Software