ISO 13485 Certification in Yemen

Certvalue is professional ISO 13485 Consultant in Yemen, providing ISO 13485 Certification in Yemen, Sana’a, Aden, Taiz, Al Hudaydah, Ibb, Dhamar, Habban, Sadah with the assurance of training, Audit, Documentation, Certify, Templates, Gap Analysis, Implementation, Registration, Consulting services at affordable cost to all organizations to get certified under medical device system in Yemen. ISO 13485 certification in Yemen is one of the industry specific standard for quality management system on medical devices. The standard is applicable for all the manufacturers, distributors, importers and dealers across the world. The main objective behind the standard is to increase the quality of the manufactured medical device in order to deliver across the world. And this is one of the complicated and sensitive sectors which has to be taken care. The standard has been recently revised in the year 2016 which focuses more on the risk management which is very much strict compared to the previous version. Management commitment and dedication is one of the key areas where the standard is focusing on. As per analysis it was noticed that providing authority to the management representative was becoming difficult in order to achieve the continual improvement. So now management has to take the responsibility in making sure that the system which has been adopted will be continuously monitored and improved. ISO 13485 Certification Services in Taiz specify the requirement on quality policy which has to be free plan approved by the top management and it has to be made sure that it will be communicated with in a company and to the external interested parties. ISO 13485 in Sana’a specify the requirement of plan, do, check and act methodology based on which you have to implement a system within your company. Technical documentation is one of the key areas which has to be documented as per the work instructions on the process. And for all of the documented process you should demonstrate the evidence to the external auditor who is coming from the certification body to audit your management system in order to certify your company.

ISO 13485 registration services in Aden specify the requirement of context of organization to be defined and documented in order to understand the needs and Expectations of interested parties which is one of the key areas which will be later focused on the risk management. Roles and responsibilities of the team have to be defined and informed to all of the employees in order to eliminate the chances of duplication of leading to wastage of time and effort. Management has to appoint a leader who will be held responsible on implementing the system within the company. He should ensure that all the documented process has to be frequently reviewed and for all of those changes happening within the process has to undergo the required change as per the Change management process. ISO 13485 registrations in Yemen specifies the requirement on framing the quality objectives based on increasing the quality of the medical devices being manufactured and it has to be tangible. To achieve the intended output it is always advice to go with smart approach which is nothing but simple, measurable, achievable, reasonable, realistic and time bound which is one of the successful methodologies used across the world in order to obtain the effective and accurate results.

ISO 13485 certification consultant in Sana’a is always best to be hired within your company in order to implement the management system. The reason being very simple that having the expertise in implementing the standard requirement in the past history and good understanding on the Standard requirements it would be very easy for the third party consultant to understand about your process and what is missing in order to meet a standard requirement. Once they understand what has to be documented based on the templates issue by the consultant it would be very easy for the process heads to document all the process and work instructions in order to demonstrate the evidence and results to the auditors who are coming for the certification audit from third party Inspection Services. ISO 13485 consultant in Yemen should make sure that availability in implementing should always be hundred percent. And this is one of the major concerned across the world handling multiple projects at a time. It should be made sure that all the required evidence on training has to be provided within the team so that the evidence can be demonstrated. The standard specifies a requirement of frequent internal auditor which is nothing but cross departmental on it based on the Standard requirement. All the evidences for the internal audit has to be demonstrated like the internal calendar, Internal audit schedule, internal audit report, corrective action report, management review meeting agenda etc. ISO 13485 audit services in Taiz are always suggested and advice to undergo at it helps to increase the brand value on the certification which you have achieved. Double checking or cross verifying system is always industry best practices across every industrial sector.

What are the benefits from the ISO 13485 Certification in Yemen standard?

  • ISO 13485 consultancy services in Aden help companies to go to next as you will be bench marking on the international process.
  • ISO 13485 consultancy in Sana’a will help your company to achieve or receive the benefits on Business expansion in the international countries which will lead to increased profit.
  • ISO 13485 Consulting Services in Yemen will help you to understand on the customer complaints which is one of the area where the standard will focus on. Complaints you have to assess each of the concern from the customers making sure that this problem will not occur in future.
  • ISO 13485 Consulting in Tiaz helps to increase the customer on to dance on the product being manufactured as it acts as an inbound marketing tool attracting the customers towards your service which is in value added profit.

How to get certified for ISO 13485 certification in Yemen?

We are one of the one stop solution provider for all of your certification requirements which are essential for any of the requirements raised by your customer or and mandatory class to be fulfilled to participate in any of the tenders. We work on end to end projects helping our customers to adopt International standards and sustain it throughout the lifetime by providing assistance even after Certification Services which makes us unique compared to others. We do not help our customers only just to document the process where as we deliver the industry best practices with which they will be benefited to increase their efficiency with in the work process. With us ISO 13485 certification cost in Yemen is always beneficial for all of our customers as we provide our quality oriented service at minimal price.

How to get ISO 13485 Certification Consultants in Yemen?

If you have any of the tender which is very nearby and you have to get your process certified and you are confused how to get ISO 13485 certification in Yemen. You do not have to worry on this you can just rely on us to get your business certified at minimal time which is our strength. You can write to us at [email protected] in order to share the certificate requirements to us or visit our official website at to know more about our company and our services delivered across 30 different countries. You can register your certification requirements with our certification personal or help desk personal who will be made available 24/7 in order to assist you on your certification requirements and clarifications. One of our Consulting experts will get back to you on the certification requirement in order to understand about it 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


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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