ISO 13485 Certification in Egypt

ISO 13485 Certification in Egypt is the best certification for medical device manufacturers and suppliers dedicated to ensuring the highest quality and safety standards. This widely accepted standard creates the basis for quality management systems specifically for the medical sector, assisting Egyptian businesses to adhere to rules, improve product quality, and put patient safety first. 

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Certvalue is one of the best ISO 13485 Consultants in Egypt & ISO 13485 Certification in Egypt, Cairo, Giza, Alexandria, Shubra AI Khaymah, port Said, Luxor, Mansoura, Suez and all major cities in Egypt. With the Services of implementation, training, documentation, gap analysis, registration process and audit, templates at affordable cost to all organizations to get certified under Pharmaceutical of Medical Manufacturing in Egypt. ISO 13485:2016 certification in Egypt is one of the process certification defined and published by international organization for standardization. The standard is applicable to the medical industries on manufacturers, distributor, retailer and importer as this is an industry specific standard. This is a management system which is auditable and certifiable standard which has been recently revised in the year 2016. The new version of the standard is focusing more on the risk approach which makes the system much more stringent compared to the older version. ISO 13485 Certification Services in Cairo define the requirement of leadership quality within the system in order to drive system and achieve the intended results out of it. Management is supposed to take the leadership in their commitment and direction in order to implement the standard but it is always understood that being a business head you will always be busy in your day-to-day activities. So standard provides you the flexibility to delegate your work to any of the dedicated employee as a management representative or a leader in order to monitor and implement the standard requirement. ISO 13485 in Alexandria define to document on your process and work instructions in order to identify the hidden loopholes within the system.

ISO 13485 registration services in Luxor now has made quality manual no longer mandatory which reduces the maximum documentation involved within the requirement. ISO 13485 Certification in Egypt the term document and record has been replaced to documented information in order to overcome the confusion caused in the previous version. Some of the mandatory documented information like control of documents, control of non conformity, control of Management review meeting, control of internal audit, control of Preventive action should be documented in order to drive the system. ISO 13485 registration in Egypt define to document all the roles and responsibilities of the employees working within the company. It is always best advice to that you have a quality committee within the organization, whose roles and responsibility can be bifurcated in order to overcome the confusion.

ISO 13485 certification consultant in Cairo specifies the requirement of internal audit to be conducted at frequent intervals. The standard specifically demands to undergo one internal audit every year, but to have a stronger system in place you need to conduct at least 2 internal audit in a year. ISO 13485 Certification in Shubra AI Khaymah in order to achieve the results from internal audit your oddities and the auditor should have the right skills and knowledge on audit techniques. ISO 13485 consultant in Alexandria should help you to provide the awareness on increasing the competency. ISO 13485 templates in Egypt for the competency delivered to the team you should have an evidence in terms of certification. Post completion of internal audit you are supposed to conduct a management review meeting which will help to take a decision on the identified loopholes within the process. ISO 13485 audit services in Luxor will always be advised in order to achieve maximum benefits as it’s cross check the hidden loophole which were not identified during the implementation status.

What are the advantages from the standard?

  • ISO 13485 consultancy services in Egypt can help your company to be recognized worldwide resulting in increased global presence which will directly impact on the profit margin.
  • ISO 13485 consultancy in Cairo will help to achieve the Business expansion opportunities in the international countries.
  • ISO 13485 Consulting Services in Luxor can help to win maximum orders from the government as it is one of the mandatory requirements to be certified with in order to participate in any of the government tenders.
  • ISO 13485 Consulting in Egypt will help you to export your product to any international market due to the increase the confidence within the product.

How to get certified for ISO 13485 certification in Egypt?

We are one of the market leaders for consultation and certification of all kinds of international standards which are available in market. We have consultants with us who have a vast experience in the standard requirements and on the industry specific domains which makes us to provide the industry best practices to our customers other than implementing standard requirement. We believe in customer satisfaction not just certification on documentation. We will help our customer with the minimal documentation in order to comply with the standard requirement. With us ISO 13485 certification cost in Egypt is always minimal for all of our customers across the world which makes us better compared to others.

How to get ISO 13485 Consultant in Egypt?

If you are looking how to get ISO 13485 certification in Cairo you are at the perfect storm as we are one of the one stop solution provider for all of the certification requirements at affordable cost and minimal time. You can write to us at contact visit our official website at to know more about us and our Consulting experience. Our help desk personal will always be available 24/7 to assist you on your queries where you can register yourself by providing your contact details so that one of our experts will contact you at the earliest in order to understand about your company and your certification requirement.

Checklist for ISO 13485 certification in Egypt

 The ISO 13485  Certification Audit Checklist covers the seven main areas of the ISO 13485  Standard:

  • Context of the organization
  • Leadership
  • Planning
  • Support
  • Operation
  • Performance evaluation
  • Improvement


Certvalue is a reputable and widely recognized global leader in the provision of certification, advice, audit services, and ISO 13485  Consulting Services anywhere in the world. It operates ethically and has an unmarked track record of achievement in the certification process. Certvalue ISO 13485 consultants have a wide range of knowledge and expertise in many fields and industrial sectors. Organizations pick Certvalue to handle complex solutions because of the service’s superiority. With Certvalue, registering for ISO 13485 certification in Egypt is simple and fast.

The cost of obtaining ISO 13485 certification in Egypt can vary widely based on several factors. The easiest way to get the cost is using our Free cost calculator and get the cost for your ISO 13485  Certification instantly in your email.

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Asked Any Questions

An international standard called ISO 13485 was created especially for the medical device sector. It provides specifications for a quality management system (QMS) targeted at the creation, distribution, and design of medical devices.
As it guarantees regulatory compliance, improves product quality, lowers risks, and demonstrates a dedication to patient safety and product efficacy, ISO 13485 is crucial for businesses in Egypt's medical device industry.

The ISO 13485 accreditation is advantageous for businesses in Egypt engaged in the design, development, production, and marketing of medical equipment. This covers producers, providers, and distributors of medical devices.

Initiating the certification project, carrying out a gap analysis, putting in place an approved quality management system, conducting internal audits, applying for certification from an accredited authority, and maintaining compliance are the typical procedures.


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

Process for ISO Certification in Bangalore

Certvalue make the ISO certification process in a simple way for every organization in bangalore to get their certification sitting at their place in lesser time and at an affordable cost.

Get Consultation

Seek guidance from Certvalue to determine the relevant ISO standards.

Submit Your Documents

Collect and prepare the required documents and records.

Get Audited

Undergo a thorough audit by Certvalue’s auditors to assess compliance.

Get ISO Certificate

Upon successful audit, receive your ISO certification from Certvalue.






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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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.
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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.
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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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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.
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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.
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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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