ISO 13485 Certification in Nigeria

Certvalue is one of the best ISO 13485 Consultants in Nigeria & ISO 13485 Certification in Nigeria, Lagos, Ibadan, Benin, Calabar, Jos, Owerri, Akure, Abeokuta and all major cities in Nigeria with the Services of implementation, training, documentation, gap analysis, registration process and audit, templates at affordable cost to all organization to get certified under pharmaceutical of medical manufacturing in Nigeria. ISO 13485 certification in Nigeria is an important certification standard to improve the quality standards followed by the industries and organizations. Nigeria belongs to the west Africa. It is often referred to as the Giant of Africa, owing it its large population and economy. It is the seventh most populous country in the world and 20th largest economy in the world. It is classified as mixed economy emerging market. From only exporting it’s natural resources and raw materials growth of industrial sectors and organizations have made some remarkable changes by manufacturing and exporting the ready goods. Nation in abundant in natural resources. Oil, overseas remittances, Service based organizations, mining, manufacturing are the major source of GDP. ISO 13485 in Nigeria is a must and should standard certification to gain potential stability in the emerging medical device marketplace.

What standard is all about?

Any part of the world, major importance are given to two factors. One is education and another is Medicine. And also these two domains are the big business sectors in the market today. But then medicines and related services are very critical as it directly related to welfare of human society. ISO 13485:2016 certification in Nigeria is the best possible solution for an organisation involved in complete cycle of medical devices manufacturing and related service. Its requirements are quite simple that quality management system and other technical requirements related to the medical equipment and medical devices manufacturing and other related services. ISO 13485 consultant in Lagos can implement the standard at its best. Establishes a Framework for an organisation to effectively manage the quality and the safety of the Medical components weather related Medical Services. ISO 13485 consultant service in Ibadan could show path for successful implementation. Consequences of non compliant with the medical related directives and other regulatory and statutory requirements will lead organisation into a penalization and the penalty will be huge.

Quality and technical documentation requirements:

  • Classify the devices: Pharmaceutical of Medical Manufacturing in Nigeria the first job of Technical filing is classifying the devices or equipment that are manufactured by the organisation. A medical device manufacturing industry will not have single equipment manufacturing which is produced in massive quantity.ISO 13485 consulting service in Kano van help in classification. There will be many class of products produced and every products should be classified to the belonging category and filed.
  • Conformity document: ISO 13485 Certification in Lagos each and every product again classified and filed in a document should the given with reference regulatory directives related to medical directives. The conformity document should comply with the ISO 13485 audit in Nigeria and other applicable medical directive regulatory standard.
  • Description of the product: ISO 13485 Consultant in Ibadan each category of the product should contain technical documentation of describing the product specification and the class it is been categorized ISO 13485 certification audit in Benin city can help you with the entire process. ISO 13485 templates in Nigeria the descriptions of file should contain the data such as manual on how to use a product or equipment its name, its number, its code and everything has to be disclosed in the document.
  • Defining the procedure for each product category: ISO 13485 in Benin defining the procedure not only defines on how to the product has been manufactured but also streamlines the process performed internal to the organisation. Deep briefing about test product in the form of a procedure helps in many ways. ISO 17025 certification bodies in Nigeria can help your organization certified. It also helps in curing the awareness about the product to the newly appointed employee which helps in training them and also briefing about the product to the customers, interested parties and stakeholders.
  • Specification of the product: This is a requirement which rather goes deep into the dimensions of the Medical product being manufactured.ISO 13485 audit service in Nigeria is an helping hand. This document should contain the critical dimensions of the product comma material specifications, manufacturing specifications.
  • Service and installation procedure: ISO 13485 Service in Calabar this specification is very specific and exclusive only two few of the product categories. This file should be maintained only for the weak wire requirement for the peculiar product or service. It should contain the technical documentation and procedure of installation and service being delivered by the manufacturer or service provider.Cost of ISO 13485 in Nigeria is a pretty good investment for long term benefits. It should contain the steps for installation and it has to be recorded in the form of a document and also the time frame for maintenance, repairs and servicing the product on a regular basis.

Of course the advantages of the standard are enormous for the organisation involved in manufacturing and other related activities of PMM Certification in Nigeria.One should be wise enough to extract all the benefits out of it. ISO 13485 certification cost in Nigeria is worth investment walking your organization towards success.

How to get ISO 13485 Certification in Nigeria?

If you are looking how to get ISO 13485 certification in Nigeria It is no more a confusion but choosing Certvalue which is going to be your one stop solution providers on implementation, guidance, documentation, consultation, audit and certification. ISO 13485 registration in Nigeria is simple and genuine with the help of Certvalue. You can easily reach Certvalue by simply visiting where you can chat with an expert or you can also write an enquiry to [email protected] so that so that I can coordinate you with our consulting experts who shall contact you at the earliest to provide best possible solution available in the 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.
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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
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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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