ISO 13485 certification is an ISO standard applicable for manufacturers of medical components, in other words, for medical device companies. ISO 13485 provides guidance to create an effective QMS which ensures quality of the product and service offered by the companies.

ISO 13485 allows your organization to certify your system according to the quality system requirements as well as regulatory statues. An international team of experts have developed these standards to manufacture medical devices.

The standard also helps companies design, produce, install, and develop services related to medical devices. Medical device manufacturers need to implement a reliable quality management system in the processes involving the development, production, design and servicing of medical devices and in vitro diagnostic devices to create trust.

The international standard ISO 13485 forms the basis for the certification of quality management systems in companies that manufacture or distribute medical devices – or participate in their manufacture as part of the supply chain.

Benefits from the ISO 13485 certification in South Africa

  • ISO 13485 in Cape Town acts as a proof of compliance with the relevant guidelines for the manufacture of medical devices
  • ISO 13485 in Durban brings about an increased efficiency in the company
  • ISO 13485 in Johannesburg assures higher profits at lower risks
  • ISO 13485 in Pretoria is a proof of the fulfilment of all industry related requirements.

ISO 13485 certification in Africa involves the following process:

  • Informative introductory meeting
  • Documentation review
  • Certification audit
  • Certification
  • Regular surveillance audits
  • Annual monitoring to ensure proper implementation of requirements in practice
  • Re-certification

We are working towards becoming one of the best ISO 13485 consultant in Cape Town for companies involved in the design, manufacturing, and distribution of medical devices, mainly non-risk devices.

ISO 13485 Certification in Cape Town by Finecert improves the efficiency of your business to increase profits. Our experts have many years of experience in the field of certification of ISO in South Africa.

How to get ISO 13485 Certification in Cape Town?

To assist your organization with all the ISO 13485 requirements, we at Finecert are confident of using our expertise in providing your organizations with the ISO 13485 in Johannesburg & also the ISO 13485 in Cape Town. The next thing you would be interested in is to know your investment required for this process.

We are one of well recognized ISO 13485 Certification consultants in Cape Town and our ISO 13485 cost in Cape Town is always affordable to any organization in every industry sector. Finecert aims to provide the ISO 13485 certification in Pretoria at an affordable cost. We also assure you that the cost of ISO 13485 in Durban is very much affordable if you get back to us with your requirements.

We, at Finecert, are competing to be one of the top ISO 13485 consultants in Cape Town. With our rich experience in handling clients across various industries, we assure to help your Organization in implementing the ISO 13485 in Africa & getting the ISO 13485 certification in Cape Town. Having an ISO 13485 in Johannesburg is sure to benefit your Organization as it shows your interested customers of the importance you give to maintain a Quality process in your Organization.

We strive to provide the best ISO 13485 certification in Johannesburg as well as to be the best ISO 13485 consultants in Johannesburg with the services we provide to organizations.

ISO 13485 certification in Cape Town by an accredited and respected certification body is nowadays being demanded from suppliers and business partners by organizations that are concerned about the Quality of Services being provided to them. Finecert will assist you with the best ISO 13485 services in Cape Town to make sure that your organization gets ISO 13485 certification in Cape Town from among the top Accreditation bodies.

To know more about how you can get your organization ISO 13485 in Cape Town or ISO 13485 in Johannesburg, you can write to us at contact@finecert.com or visit www.finecert.com and provide your details so that we can contact you to discuss on how we can best assist you.

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