ISO 13485 Certification in Ethiopia

ISO 13485 Consultants in Ethiopia is a professional consultant for providing ISO 13485 certification in Ethiopia, Addis Ababa, Dire Dawa, Harar, Mekele, Nazrēt and other major cities in Ethiopia with the services of implementation, Documentation, Audit, Templates, Training, Gap Analysis, Registration at affordable cost to all organization to get Certified under Pharmaceutical of medical manufacturing in Ethiopia. ISO 13485 Consultants in Ethiopia identifies requirements for a quality management system where an organization needs to signifies its ability to provide medical devices and related services that frequently meet customer requirements and regulatory requirements relevant to medical devices and related services. The foremost objective of ISO 13485 Certification in Ethiopia is to facilitate correlate medical device regulatory requirements for quality management systems. As a result, it includes some distinct requirements for medical devices and excludes some of the requirements which are not appropriate as regulatory requirements. The medical device manufacturing section is one of the most regulated section in which significant-quality systems and product requirements must be satisfied

Requirements to ISO 13485 Certification Process in Ethiopia corporation that wants to be certified has to fully and verifiable to meet all the requirements of the applicable standards. The other things, that the following requirements have to be fulfilled:


  • A Quality Management System has to be adopted, recorded, and implemented and the regulation of this system has to be maintained. ISO 13485 Certification Services in Ethiopia has to meet the requirements of the ISO 13485 Certification in Dire Dawa.
  • The defined procedures have to be implemented and adopted which also means that the employees have to be consequently educated.
  • Risk management has to be covered in the whole process of product development.


ISO 13485 in Ethiopia is the international standard for quality management systems for medical devices. We inspect your quality management practices for medical devices, focusing on development and design, production, customer service, and assembly. advantages from the positive effects of a quality management system: smooth processes, efficient workflows, and international recognition.

Which industries are applicable to ISO 13485 Certification in Ethiopia?

ISO 13485 Certification Services in Addis Ababa proves your commitment to the quality of medical devices

Reasons to Implement the ISO 13485 Consulting Services in Ethiopia?

Improve your processes Using the operation approach outlined in ISO 13485 Implementation in Ethiopia, it’s much easier to identify opportunities for improvements.

Improve decision-making Another quality management principle of ISO 13485 Audit in Ethiopia regards the use of verification-based decision making. When you use actuality and data to drive your decisions, those decisions tend to be better arranged with the strategic goals of your company.

Improve your company’s credibility and image ISO 13485 in Ethiopia is the central recognized gold standard for quality in the medical device industry. Certification to this standard shows customers and clients that your company takes quality very seriously, and that you have a system in place to ensure it.

 benefits of ISO 13485 Certification Services in Ethiopia?

  • ISO 13485 Consulting Services in Ethiopia Demonstrates that your products are safer and productive medical devices.
  • It Increases entrance to the world’s market with ISO 13485 Services in Ethiopia.
  • ISO 13485 Consultants in Ethiopia Improves the operation in medical device manufacturing, packaging & supply.
  • Increase efficiency, cut costs and record the supply chain performance.
  • Meeting regulatory/statutory requirements and customer assumptions.

 How to Get ISO 13485 Consultants in Ethiopia?

Certvalue is a Best Leading ISO 13485 Consultants in Ethiopia that improve competitiveness for providing quality management systems for medical devices. ISO 13485 Consulting Services in Ethiopia are one of the well-recognized with Specialists in every Industry Segment to put in force the widespread with 100% continuous of accomplishment. If you are searching you need help with ISO 13485 Certification cost in Ethiopia, you can fill out our popup form in website or expert free to send your inquiry to [email protected] our Talented Professionals are handling to make clear your doubts and requirements.

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Our Services


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
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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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