(EN) ISO 13485:2016 - The Role of Consultants

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.

The role of (EN) ISO 13485:2016 Consultant is crucial as the Implementation is mainly for the regulatory purpose. Regulatory purpose means, it is MUST by LAW in some countries.


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

The Importance of EN ISO 13485:2016 consultant is important at this moment. I would like to take your attention; the Quality Management Consultant and medical device regulatory consultant are different.

If you are a just a distributor and not planning to affix CE Marking you can appoint a QMS 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 technical consultants for 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, regulatory consultants, focus mainly on medical device and IVD companies, so we understand the unique needs and manufacturing scenarios of the industry. Our consultants are EN ISO 13485:2016 lead auditors and approved internal auditors. With offices in Germany, India and USA and our team of experienced medical device consultants has helped hundreds of medical device and IVD manufacturers in 14+ countries achieve ISO 13485 certification.

Our team of 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 from India office wherein a pool of full time technical and documentation staff equipped to take up the job and complete on time by guarantee you will pass your first EN ISO 13485 certification along with CE Marking audit if you follow our plan. Few more benefits are listed below:

  • 1. Qualified and experienced medical device ISO 13485 consultants
  • 2. ISO 13485 Certified Lead Auditors
  • 3. Largest fool of full time technical 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

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