ISO 13485 Certification in Turkey

ISO 13485 Consultant in Turkey is a professional consultant for Medical Devices providing ISO 13485 Certification in Turkey, Ankara, Adana, Edirne, Eskisehir, Bursa, Mardin, Istanbul, Antalya, Izmir, Canakkale, Trabzon and other major cities in Turkey with the services of implementation, Documentation, Audit, Templates training, gap analysis, registration process at affordable cost to all organization to get certified under pharmaceutical of medical manufacturing in Turkey.  ISO 13485 Certification is medical devices quality management system on this is one kind of industrial specific standard with established by international organisation for standardization which has till date published more than 21500 standards all together and it still in the process of releasing more and more number of standards every year it just does not published the standard but also depending on the requirement and development life cycle it also revises the standard which it has published earlier but in a stipulated amount of time with which the industries can get the benefits of the developed economy and also the technology which will be improving as the time goes on.

This particular standard focuses on the organisation which manufacture medical devices and medical equipments the major emphasis of the standard is the medical devices which are reaching the end user has to be technically sound and should not include any of unsafe products or specifications which can be harmful are grateful to the end user or the patient on which the particular medical equipments is being used.

ISO 13485 certification in Turkey will help organisations in many different aspects, standard is implemented into the organisations it brings in lord of quality and also efficiency and effectiveness into the management system practices which are being performed. Standard also includes each and every regulatory requirements which have been set by the regulatory authorities of different country right heel, Australia rock commercial different organisations so this is a very good Framework for any organisation which is started up in any kind of medical field in any country can take advantage of implementing ISO 13485 in Turkey into their organisation and can witness a great change in their practices.

Not only the regulatory requirements but also the customer requirement have to be satisfied to make sure one organisation is complaint completely with the ISO 13485 in Istanbul. ISO 13485 services in Ankara will help the organisations to have the characters and reliability on the products which are manufactured in their organisation and also the process cycle of the manufacturing has to be under watchful eyes and each and every stage of manufacturing cycle has to go under watchful eyes and also the records have to be maintained to make sure there is an evidence of whatever number of products have been Manasa and what is the time taken to manufacture each and every unit of it.

Unlike other generic standard this particular standard have some specific differences which are mentioned below

  1. Awareness and promotion of regulator requirements is a management responsibility and have to be incorporated into the organisation by giving training to each and every employee present in the organisation
  2. Controls have to be maintained in the work environment to ensure that the product which is manufactured is safe.
  3. Risk management has to be mandatorily performed as an activity and also design control activity has to be practiced during the product development so more focus has to be kept on these two aspects during the implementation of ISO 13485 in Izmir.
  4. Specific requirements for inspection and traceability of devices which are implantable has to be taken care as well.
  5. Specific requirements for documentation validation of the process for sterline medical devices has to be in place so that nothing is going out of monitoring and watchful eyes.
  6. Corrective and preventive action along with verification and effectiveness have to be maintained in accordance with the intended plan to make sure that everything is working according to what was intended to be.

Sober looking at all the above requirements of the standard one can easily say that it is really difficult for an organisation to implement ISO 13485 into their management system without the help of any ISO 13485 consultation service provider in Turkey. Show there is always a need to hire and ISO 13485 certification consultant in Adana who will help you and guide you what the process of implementing ISO 13485 istanbul without eliminating any of the above mentioned parameter. And also ISO 13485 certification cost in Turkey totally depends on the consultant who is hired so make sure you select the right ISO 13485 consultation service provider in ankara to have a reasonable cost of ISO 13485 in Turkey.

Certvalue is one of the leading ISO 13485 consultation and certification service provider in Turkey who will help you in all possible ways to get your ISO 13485 in Turkey so don’t waste any time and get in touch with us as soon as possible by visiting our website and fill up the pop up form or chat with us online to communicate your requirement with us. We will make sure that you get 100% Certified because we have hundred percent track record of success and also hundred percent customer satisfaction level for all the customers to whom we have implemented ISO 13485 certification in Adana. And also will promise that also ISO 13485 Certification cost is always reasonable and affordable from us.

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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.

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Our Client Reviews

Sobiya Rajesh
Sobiya Rajesh
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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
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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
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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
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Amazing organisation to work with! Certvalue is definitely the best of the best. Thank you Certvalue Team!
Shehan Athukorala
Shehan Athukorala
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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
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We got good service from certvalue and its team I was satisfied,thank you Certvalue for making my work easy
Mounika Kona
Mounika Kona
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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
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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
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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!
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