ISO 13485 Certification in Saudi Arabia

Best ISO 13485 Consultant in Saudi Arabia, for providing ISO 13485 Certification in Saudi Arabia, Riyadh, Dammam, Jeddah, Medina, Al khobar, Mecca, Jazan, Tabuk, Buraidah, jubail and other major cities in Saudi Arabia with the services of implementation, training, documentation, gap analysis, registration, Audit and templates services at affordable cost to all organizations to get certified under all Medical Devices management system in Saudi Arabia. Healthcare and medical manufacturing industry is one of the critical Industry sector compared to the industrial sectors. Here minor to minor mistake will lead to heavy impact on human on consumption or using the equipment. ISO 13485 certification in Saudi Arabia is always strictly advised for all the Healthcare and medical manufacturing industries who manufacture medical products. The standard helps you to minimize the risk which month result in use impact in the future during the initial manufacturing stages. kingdom of Saudi Arabia- KSA, ISO 13485 in Saudi Arabia has helped maximum industries in the City to maintain the quality of the products being manufactured. This is a generic started which specifies the requirement for quality management system for medical devices. This is a industrial specific standard which can be applied only for medical manufacturing industries.

Certvalue helps for medical devices certified under ISO 13485 in Saudi Arabia. We are the most successful ISO 13485 Certification Consultants in Saudi Arabia. We have strong technical experts to do ISO 13485 consulting, ISO 13485 Implementation, ISO 13485 Audit, ISO 13485 Gap Analysis and ISO 13485 Internal Audit. We do provide end to end services starts from Gap Analysis to get certified your product under ISO 13485 in Saudi Arabia. ISO 13485 cost in Saudi Arabia is affordable with our experts. We do have expertise to do consulting many sectors like ISO 13485 for Medical Sectors, ISO 13485 for Manufacturing Companies, ISO 13485 for Health care Sectors, ISO 13485 for services sectors in Saudi Arabia. ISO 13485:2016 Quality Management System for Medical Devices in Saudi Arabia and Requirements for Regulatory Purposes.

ISO 13485:2016 Certification in Saudi Arabia  has drastically increased in the recent years due to its maximum benefits in protecting you and your organization from future risk which might lead to heavy penalties, human injuries, loss and company Lockout. ISO 13485 registration services in Dammam will help you to streamline your organization process which will result in increased efficiency leading to reduced wastage, increased customer satisfaction, reduced employee retention problems and increased benefits. ISO 13485 in Al Khobar will make sure that all the risk identified will have mitigation Plan which will prevent the risk is popping out in future. It is one of the heavily implemented standards within the kingdom due to its immense benefits.

ISO 13485 in KSA will help you to avail the maximum benefits from the standard requirement. As being a company stakeholder or a process head it is understood that you will always be busy in your own business schedule. It is always best advice that you hire ISO 13485 consultancy services in Jeddah so that they will help you to implement the standard requirement as a helping hand to comply with the standard and achieve maximum benefit out of it.

ISO 13485 certification in Jeddah as discussed in the previous section it is one of the industry specific standard applicable only to the medical manufacturing industries. This standard can be implemented respective of number of permanent employees working within the organisation, number of contractors involved, location and other factors. ISO 13485 certification in Saudi Arabia is one of the standard evolved from quality management system and this is one of the prerequisites for the product certification. In the case where the medical manufacturer has to undergo the product certification it has become mandatory that the organisation is certified to ISO 13485 certification in Riyadh. As medical sector is considered to be one of the critical industry it is always recommended that to be on a safer for side, ISO 13485 certification in Saudi Arabia has been implemented into end to end. Every country across the globe have a strict legal requirements and export requirements for medical manufacturers to sell their product within the country or to export into International markets. In some of the markets for example European markets in order to export your medical products it is very much mandatory that your organisation is certified to ISO 13485 certification in Al Khobar. Below section which described on mandatory documented information required in order to get compliant to ISO 13485 certification in Saudi Arabia has to be made available as per the standard requirement.

ISO 13485 Certification process in Saudi Arabia:

  • Procedure for complaint handling: ISO 13485 Certification Services in Saudi Arabia specifies the mandatory requirement that there should be a procedure being defined and documented on complaint handling. As per industry best practices this is one of the tool with which you can understand your mistakes in order to achieve improvement within your process. Some of the organisation frequently misunderstood that with the help of ISO 13485 Certification Services in jubail achieving complaints would be a negative factor leading to business disaster. Every organisation across the world exits for one and only factors that is success or profit. Success or profit can only be achieved by customers who are fully satisfied and as per ISO 13485 Certification Services in Riyadh, organisation who are successful in business have there existing customers taking services from really long time. ISO 13485 Certification in Dammam will make sure that you have a standard on how to receive the customer complaints, how to investigate the complaint, how to find out the root cause for the problem and provide the solution to the customer so that the customer who has taken services from your organisation is kept happy as per ISO 13485 Certification Services in Al Khobar.
  • Procedure for customer feedback: ISO 13485 certification in Saudi Arabia specify the mandatory requirement that there should be a necessary customer feedback system in place. Feedback is only one tool with which you can understand the level at which your customer is satisfied with the received services or products from your organisation. As per ISO 13485 in Dammam, customer who are extremely happy or extremely unhappy will only provide the feedback. Majority of the organisation have reported that it is very difficult to obtain feedback form from the customer with which you should understand that your customer is happy moderate and you should make the necessary controls in place with which you can upgrade the moderate happy customer into fully happy and satisfied customers so that you retain the existing customer for a longer time.
  • Procedure for traceability: ISO 13485 registration in Saudi Arabia specifies the requirement that there is a necessary standard or a process / procedure has been defined and approved by the management which helps the team to easily trace the documentation. As per ISO 13485 registration services in Saudi Arabia traceability is one of the area to be focused on as maximum organisation have created the documentation and put a new system but failed to trace the required management system.
  • Procedure for maintenance activities: ISO 13485 in Jeddah specifies the requirement that the organisation should have the necessary procedure in place which is documented that describes on the maintenance activities of the medical products. As per ISO 13485 in Saudi Arabia you should have all the necessary evidences on the vendor or the third party organisation who is performing the maintenance activities to your medical products. The procedure should necessarily have the time duration on which the each product has to be maintained or serviced. ISO 13485 audit in Saudi Arabia ISO 13485 audit services in Saudi Arabia specifies the necessary evidences for the previous maintenance or service undergone. Also some of the orders will also check for the vendor register in order to match with the servicing report.
  • Procedure for validation: ISO 13485 certification in Saudi Arabia has to make sure that there is a necessary system in place for the validation of medical products. In order to define the procedure for validation you should first have a clear understanding on the differences between verification and validation. As per ISO 13485 certification agency in Saudi Arabia ISO 13485 certification body in Saudi Arabia verification is something which you compare with checklist for accurate result as per the intended specification. Validation is nothing but where you verify for an accuracy whether it meets the customer requirements.
  • Purchasing procedures : ISO 13485 consultants in Jeddah has to make sure that necessary procedures on purchasing activities within the organisation has to be documented by a standard process. Purchase department would be the owner with respect to designing, developing and maintaining this procedure as per ISO 13485 consultants in Jeddah. Within the procedure you have to include on how to select vendors who will provide services to your organisation, how to evaluate the vendors post receiving the quotation, how to select the vendors post evaluating, how to negotiate with the vendors has to be documented as per ISO 13485 consultants in Riyadh. Purchasing has been considered as one of the key areas as quality of the manufactured product is directly linked with the raw material being outsourced for the manufacturing process. As per industry best practices of ISO 13485 consultants in Dammam it is always best suggested that you frequently audit your vendors on the ground of quality so that you are double sure on the raw materials being supplied for your manufacturing process is quality oriented.
  • Procedure for design and development: ISO 13485 consultant services in Saudi Arabia has to make sure that procedure for the design and development of the medical product has to be documented. This is one of the confidential document which should be restricted from using the document. As per ISO 13485 Consulting Services in Saudi Arabia any changes to the design and development has to be updated in the procedure document so it becomes mandatory for an organisation to review the procedure at regular intervals. ISO 13485 certification consultants in Saudi Arabia specifies the mandatory requirement that there should be a procedure followed On the Change management.
  • Risk management: ISO 13485 consultants in Saudi Arabia specifies the new requirement who has been brought into the standard that the organisation should have a necessary procedure on risk management. Preventive action has been rolled out from the standard requirement as the standard has been upgraded to a preventive approach. ISO 13485 consultancy services in Saudi Arabia do not specifically demands for a quality manual but as an industry best practices it is always well and good if you maintain a quality manual which specifies the some of the important information on quality policy and objectives.

In order to know more about ISO 13485 certification in Saudi Arabia we request you to register your certification requirements so that we understand more about your organisation and the plan with which we can train you more about the standard requirements.

How to get ISO 13485 Consultants in Saudi Arabia?

We are one of the top rated consulting organizations who can help get your business certified at cost effective and time effective ways. We are one of the leading consulting firms who has hundred percent track record of success in terms of project completion. We are one the recognized ISO 13485 certification consultant in Dammam who has vast expertise in implementing the standard requirement. We will make sure that your organization will implement the entire requirement from the standard and comply with you certification requirement. We being ISO 13485 consultant in Al Khobar or more focused on helping our customers to implement the standard and achieve maximum benefit out of it. We believe in minimal documentation and continual improvement. We help our customers to implement the documentation by providing the tailor made templates which will help to implement the standard very easily. With us the cost of ISO 13485 certification in Saudi Arabia is always affordable for all the organization across every industry sector which makes us unique compared to other Consultants.

How to get ISO 13485 Certification in Saudi Arabia?

If you are confused or worried how to get ISO 13485 certification in Jeddah you do not have to take tension we are the one stop solution provider for all our customer requirements. You can write to us at contact to register your requirements or visit our official website on and providers your contact information so that one of our experts will contact you at the earliest to understand your requirements better and provide best available solution in market.

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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


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


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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


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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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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.
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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.
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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.
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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.
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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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