It is well-known, that for medical device manufacturers or suppliers who are looking for opportunities to enter new markets, conformity with regulatory requirements is a mandate. If you are one of those companies who want to take a competitive advantage in the medical device manufacturing industry, ISO 13485 certification will be the right choice.

The main question you might have is what benefits can ISO 13485 certification provide for your company?

Here are some of the long-term benefits of ISO 13485:
✓ A good QMS system will boost product quality, enhance efficiency and improve customer service within your company.
✓ ISO 13485 is a necessary requirement for access to most markets worldwide.
✓ ISO 13485 certification requires efforts to maintain it. This gives additional credibility for your product and for your company.

In other words, ISO 13485 helps your company to improve its competence and industry awareness and eventually increase your company’s profitability.

JERELO can help you to implement ISO 13485 or reassign from ISO 9001.

We are specialized solely on medical device industry, so we have a good understanding of the sphere and know the unique needs of your company.

We’ll perform on-site ISO 13485 training for your key employees as part of the implementation project. JERELO will fully tune your ISO 13485 quality system to meet your specific needs and make sure you are ready for a certification audit.

For more information on our ISO 13485 consulting services, please contact JERELO:
☎ +38 095 692 26 08 (WhatsApp)
✉ daria.abulova@jerelo.eu

For all questions regarding the regulation of the sphere of medical devices, you may always contact us by phone +38044 360 30 11
Our experts will advise and assist in preparation of any necessary documents.