ISO 9001 certification

ISO 13485 Certification in India

ISO 13485 certification in India is one of the Quality Management standard  for medical devices and related services companies it has been published by international organization for standard which outlines the requirement on safeguarding all of those business information.


Corporate Image

Are you facing problems in corporate recognition?

Enhanced Performance

Do you wish to increase process efficiency and effectiveness?

Professional Consulting Company


Consultation is an act
of providing professional
advice on customer challenges
that encounters while
Stepping towards
better tomorrow

Business Expansion

Do you wish to expand your business in international markets?

Profit Maximization

Do you wish to increase bottom-line of your organization?

Let us know some of the important details and learnings about ISO 13485 certification in India. India is one of the well known and one of the most quickly developing countries in the world from past 3 to 4 decades India has made significant advancement in the technology and the development of the nation, everyone is aware of their mission to Mars and the moon which showcases their ability in doing the big things which I only the reach of the most developed countries but India has gone for the step ahead and demonstrated to the world that they are not behind any other country and their very much capable of doing everything by their own. India has developed itself into each and every field of work and it now has one of the largest industrial sector and thousands of companies start in this country every single day. It is home to the most start-ups in the world and some of the cities like Bangalore, Mumbai and Delhi are world famous cities.

ISO 13485 in India just like other quality standard for cousins majorly on customer satisfaction and continual improvement ISO 13485 is quality management system for medical devices what is termed as medical devices quality management system this was written and published by international organisation for standardization this was published for the first time in 1996 and it is revised several times the latest version of ISO 13485 is 2016.

There are 8 clauses depending on which is the implementation of ISO 13485 in India carried out following are the eight clauses

  1. First one is scope
  2. Normative reference
  3. Terms and definitions
  4. Quality management system requirements
  5. Management responsibilities
  6. Resource Management
  7. Product realisation
  8. Measurement, analysis and improvement

First three clauses mentioned above or non editable and are generic classes which are present in each and every ISO standard the most important classes are clause number 4 and clause number 5. Major agenda of ISO 13485 consultation services in India is to make sure that the medical devices which are being manufactured in an organisation are up to the mark and follow every quality aspect and are safe to use.

Close number for is quality management system requirements and its nothing but the quality management system standard which defines that each and every process it is followed in the organisation has to be neatly documented into policies procedures and also objective have to be defined to make sure that there are no shortcomings to any of the requirements which are stated in the ISO 13485 certification India.

There is one closer it is really important which is nothing but management responsibilities which covers each and every aspect of having all the required things in place which are essential to make sure that the management system and the products which are being manufactured are safe and secure

Resource management, product realization and also measurements, analysis and improvements are the next following classes which by name we can understand that every single and every small thing which is being performed has to be taken care and to implement the standard by keeping each and everything in place and by making sure nothing is Mr is really difficult for an organisation solely by itself so it is always recommended that you choose and ISO 13485 certification consultant in India who will help you in all possible ways to implement ISO 13485 the organisation and also the major thing has to be kept in mind when you are choosing an ISO 13485 certification consultant in India is that ISO 13485 certification cost in India always depends on the consultants who me higher so make sure that you are choosing the right one and two hour best knowledge the right one would be Certvalue. Because they will teach you each and every aspect on how to get ISO 13485 certification in India and also will make sure that ISO 13485 certification cost in India is minimal and reasonable.

How to get ISO 13485 Certification in India?

If you are thinking about how to get ISO 13485 certification in India then all you have to do is to contact us and get one for you after our consultants I have implemented standard into your organisation will show you that doesn’t guarantee for ISO 13485 certification in India to your organisation so what else are you waiting for our address is to go for it right away right now.

All you have to do is you have to visit our website  and generate an enquiry by any of the following methods

  1. Fill in the customer intent form with all your contact details and requirements
  2. Chat online with our representatives.
  3. Chat on whatsapp by clicking the whatsapp icon on our website.
  4. Directly write to us at [email protected] with all your details

This will help us get in touch with your organisation and provide you your required certification .

Thanks for reading the blog , we are waiting for your enquiry .


Conduct Gap Analysis to find any Shortcomings from the standard requirements.


Policies, procedures, Work Instructions, Evidences, Records, Training


Conduct frequent internal audit and management review meeting.


Apply corrective actions on the identified root cause or shortcomings






Bottom-line of any business organization is profit and Customers are the only source of Profit. Certvalue will help balancing both customer and compliance requirement at the same time with the help of ISO certification


Enhancement of Performance

ISO certification is a tool to streamline and enhance the process performed internal to the organization. Certvalue indulges in inculcating best industry practices.


Recognition and Brand Value

It is always about the Brand value of your organization in the market and ISO certification from Certvalue can make your organization to be an excel and stand out in the market globally


Tender Eligibility

ISO certification is a basic requirement to bid or participate in any tenders floated by government or private sector. And ISO certification from Certvalue is an assurance win over the tenders.

Extract all the benefits of our quality consultation & implementation

Partner Us to achieve the greatest Accomplishments !!

Our Client Reviews

Sobiya Rajesh
Sobiya Rajesh
Read More
We are happy on Certvalue services. The team guided through applicable SOPs, forms and policies to implement QMS and manage it effectively so as to comply with ISO requirements. It included training part as well. Hence we are satisfied and recommend anyone who seek professional service.
Dhruv Parekh
Dhruv Parekh
Read More
Certvalue team was very professional in their approach from the time we engaged them. Special mention to Ms. Jeevika Uchil who consulted and worked extensively with our team.
Anita Okonigene
Anita Okonigene
Read More
CyberDome Nigeria Limited. CertValue made the acquisition of our ISO 27100 certification seamless. The person assigned to us Jeevika Uchil was very helpful.
Neeladri Bose
Neeladri Bose
Read More
Amazing organisation to work with! Certvalue is definitely the best of the best. Thank you Certvalue Team!
Shehan Athukorala
Shehan Athukorala
Read More
Certvalue is a very professional and responsive consultation firm. It did show us the right direction towards the ISO and GMP certifications for the PPE devices we are manufacturing. Hoping to work with them for ISO 13485 /CE and FDA as well. Well recommended for all.
Aditya vakoda
Aditya vakoda
Read More
We got good service from certvalue and its team I was satisfied,thank you Certvalue for making my work easy
Mounika Kona
Mounika Kona
Read More
Thank you certvalue, we have built information security management system in our organization with the help of certvalue. They were really help to get certified under iso 27001. Thank you.
somraj daroji
somraj daroji
Read More
Very professional in consultation, documentation etc right from the first point of meeting with them. . .thank you certvalue for all the support !
Pushkar Patwardhan
Pushkar Patwardhan
Read More
Certvalue team was very responsive right from the time we contacted them for the first time. Consultants who worked with us were very professional and demonstrated a lot of patience to get us through required documentation / requirments for the certification. Thank you Certvalue!

Application Form

Free Cost Calculator

Please Select Service type :

Scope of Certification

Download Estimate