ISO 13485 is the medical device industry’s most widely used International Standard for quality management. ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS in the medical device industry. Adopting ISO 13485 provides a practical foundation for manufacturers to address the EU Medical Device Directive (MDD), and the EU Medical Device Regulation (MDR).
ISO 13485 is one of the many services offered by TopCertifier, the global consulting and certification solutions provider. Kenya is a potentially emerging medical sector. ISO 13485 could be used by businesses in the medical device industry to improve standards and increase efficiency. We deliver ISO 13485 consulting and certification services to all major locations in Kenya including Nairobi, Mombasa, Kisumu, Nakuru.
By getting ISO 13485 certified, there is an opportunity for increased business opportunities in both existing and emerging markets. There is also a general improvement in the quality of the service/product provided to the consumer. This certification will give you a distinct edge over your rivals and will help in acquiring new clients.
We will do a FREE GAP analysis of your organization with respect to ISO 13485 Standard and give you a quote.
Once you have agreed to our quotation, Our team will provide the required trainings to you and will complete the documentation work required for ISO 13485 certification.
We will then conduct a pre assessment audit to ensure that you organization meets the desired certification requirements.
We will provide assistance during final certification audit to ensure that your organization achieves certification successfully.
We are a quality conscious organization and believe in Total Customer Satisfaction. So if you are 100% satisfied and happy with our service, make payment to us.
Our hassle free certification process has been designed to assist your company to achieve certification in just 7 – 30 days of time.
Founder & CEO
Founder & CEO
TopCertifier helped us in restructuring our system and now we have the right model to excel. We thank the team at TopCertifier for creating the difference.
The process improvement training was fantastic. Since our focus was more on process improvement than certification it really helped the team.
Did exactly what was required without going overboard. A manageable system. Worked with existing systems. It was easy to step up and improve.