ISO 13485 Certification in South Africa

Certvalue is professional ISO 13485 Consultant in South Africa, providing ISO 13485 Certification in South Africa, Cape town, Johannesburg, Durban, Pretoria, Bloemfontein, Port Elizabeth, Soweto, Germiston East London, Polokwane, Pietermaritzburg  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 South Africa.ISO 13485 certification in South Africa is the most prominent certification standard adapted by almost all the organization knowing it’s importance and significance. South Africa is officially called as Republic of South Africa is located in southern Africa. South Africa is a multi-ethnic society encompassing a wide variety of cultures, languages, and religions. Country has a mixed economy. South Africa is a very good tourist attraction and consistent economy comes from tourism for the country. Many other giant countries are helping South Africa to develop and investors are coming up to open up the free market in the country. The country is aimed to stop brain drain from the country and started operations by establishing industries and companies. ISO 13485 in South Africa is the now time to adapt by medical device and instruments manufacturing business to achieve Continual improvement and Customer satisfaction.

What is ISO 13485 Certification in Cape town?

ISO 13485 Certification in South Africa is an internationally accepted standard for manufacturing, service delivery and usage of medical devices.It establishes a framework for an organization to set up an effective quality management system for medical devices manufacturing industries. ISO 13485 certification consultant in Cape town can better implement the standard. No where in the world organization is acceptable with the compromised quality and safety of the medical device, components manufacturing and its relates service all together. ISO 13485 consultant in South Africa Medical device regulatory are very stringent regarding the safety and quality of rhetoric product being manufactured for medical utilization. It is drafted and designed to be applicable and usable by business activities involved in design, production, installation, and servicing of the medical device and instruments. ISO 13485 consultant service in Cape Town is the best possible solution. Quality management system is the basic requirement of ISO 13485 in Durban standard.

Significance of ISO 13485 Certification in Cape town documentation:

Having said that quality management system is the prime importance in the requirements of ISO 13485 audit service in Johannesburg, it is well known that the documentation should be excellent and precise for Quality Management System. Documentation is a basic necessary define the critical process. Documentation for QMS helps in training the new employees and to give or create awareness among the employees, customers, stakeholders and all other interested parties.ISO 13485 consulting service in Cape Town is an helping hand. Documentation of QMS related to medical devices used in streamlining the post process and it maintains the uniformity in manufacturing organisation. ISO 13485 certification audit in Durban will ensure QMS in the organization. The agent of behind documenting the process, procedure, policies of QMS to ISO 13485 in Pretoria is to make the process and procedure of the organisation simple and easy such that it is in the form of a white paper easily understandable by the employees of the organisation. It is going to be an ID proof for demonstrating the compliance’s to the medical detectives other regulatory obligations.

Benefits of ISO 13485 Certification in Cape town:

  • Establishing a framework for setting up effective quality management system for medical device business
  • ISO 13485 Consultants in South Africa will help in Compliance with regulatory and statutory requirements of medical directives
  • Reduces operational costs and cost due to wastage
  • Increased customer’s trust and confidence
  • Excellent training tool for employees and interested parties
  • Increased Brand value and recognition
  • ISO 13485  bodies in South Africa will increase the credibility of the organization
  • Demonstration of interest in delivering quality and safe service to the customers
  • It is good marketing tool which again a cost cutting factor by saving expenses due to advertising and marketing
  • Demonstration of social responsibility of delivering safe and quality assured product
  • Quality enhanced medical devices
  • Good Competitive advantage in the marketplace
  • ISO 13485 certification cost in South Africa will build a Quite good rapport between the suppliers and vendors
  • Streamlined process internal to the organization
  • Gaining a potential stability in the market

The advantages and benefits are far more worth the investment of the organization for Cost of ISO 13485 in South Africa. It is all about the top level management to move towards success path.

How to get ISO 13485 Certification in South Africa?

If you are looking how to get ISO 13485 certification in South Africa I would gladly prefer Certvalue with pride in ourselves for providing 100% satisfaction of customers all over the globe with consultants having expertise in different domains and industrial sectors following best practices for the customers organization. ISO 13485 registration in South Africa is an easy and simple process 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 one of our expert 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.
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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