ISO 13485 certified

We are officially an ISO 13485 certified company!

Medisol is proud to announce that we are ISO 13485 certified! The ISO 13485 certificate was specially developed for organizations within the medical device sector. The Internationally recognized certificate is a standard that manufacturers, suppliers and distributors within the medical industry can comply with, in order to demonstrate their adherence to legal requirements.  With this certification, we are one of the first defibrillator distributors to consistently meet both industry and customer requirements. 

 

What does this mean for you as a customer or reseller?

What can you expect now that we are ISO certified? Find all the information regarding the ISO 13485 certification on this page!

"We hope that this certificate will demonstrate the importance of quality and security for our products and services. Medisol wants the best for its customers and to bring us closer to our goal: in 2030 everyone will have an AED at their disposal within 6 minutes."

Founder and CEO Pieter Joziasse

Trustworthy and professional

Affiliated with a respected partner

The ISO 13485 certificate provides our suppliers, resellers and end-users with the assurance that they are collaborating with a professional organisation, that complies with legislations and obligations within the market. 

The certification further evidences the reliability of purchasing from Medisol. It is our testament that Medisol is committed and capable of delivering design, manufacturing, testing and sales services, that consistently meet customer needs and comply with legal requirements. 

Quality and safety  

Indispensable in the medical sector

Our products make the difference between life and death, therefore Medisol realises that quality and safety are indispensable within the medical sector.

How has the ISO certificate contributed to this?

Through certification, Medisol has been able to identify and implement points of improvement within our management processes. Ensuring that our own quality management system is internationally recognized.  In addition, the certification helps us to maintain quality and value throughout the chain. 

In brief, with the ISO 13485 certificate, Medisol confirms that matters concerning quality management have been implemented and are controlled in the correct manner, which enables Medisol to guarantee you, as a company or private individual, the required level of quality and certainty.  If something goes wrong, we pledge a competent complaints follow-up procedure. 

Innovation

We are on top of the game

The evolution and increasing possibilities within the medical sector, make the process of saving lives more and more accessible, therefore Medisol stays on top of the game. With the ISO 13485 certificate, Medisol demonstrates that we are aware of the necessary quality standards for medical devices and related services, required for us to comply with the Medical Devices Regulation (MDR).  

Saving Lives is our mission

One step closer

Medisol is a supplier of products that save lives. This is impossible to do without the help of people who immediately jump into action when an emergency situation occurs and it starts with the defibrillators that we offer, which comply with all protocols and rules within the medical sector. Together with our customers, we want to ensure that defibrillators are within reach everywhere.  By 2030 everyone will have a defibrillator available within 6 minutes. Only then will we have accomplished our mission together - Saving Lives. 

Medisol is always prepared for your questions!

If you have any questions after reading this information, or anything is unclear, please contact our specialists!

 

Curious to see the ISO 13485 certificate?

Download it here.