Send your request Join Sii
Send your request Join Sii
top-image
Go back

Quality in every area – Sii Poland supports the manufacturing process of medical devices with the ISO 13485 certificate

Quality and safety play an extremely important role in the manufacturing process of medical devices. Sii Poland, meeting the requirements of one of the key certificates for this sector ISO 13485: 2016 can ensure that all projects implemented for this industry comply with the strict requirements. Sii customers can count on a guaranteed level of compliance with specialized guidelines, which, among others, will facilitate the process of validation and control of a ready product.

For many, the ISO 13485 standard is associated only with the production of specific medical equipment or pharmacological products.

– Quality Management for medical devices is also dedicated to the supply chain and organizations supporting the production of medical devices from many sectors, including those providing technological services: software or statistical models helping in, for example, the selection of the target group of patients – explains Piotr Mazurski, Senior Security Specialist at Sii Poland.

Comprehensive services for the medical industry

Thanks to the development of competencies and experience, Sii can not only provide services for the medical industry but also support clients from this sector in obtaining compliance with ISO standards, including ISO 13485: 2016. It is often necessary to meet certain requirements for contractors and market regulators.

– At Sii, we specialize in providing solutions that support quality, but also safety, so we comprehensively approach the preparation and implementation process, paying attention to aspects that are often marginalized – says Sebastian Pyzik, Compliance Security Department Manager at Sii Poland.

Support in preparation for the audit

Sii is an organization with well-structured processes and repeatedly audited (ISO 27001, TISAX, or the extremely restrictive Common Criteria EAL6). Therefore, it can help its clients prepare for the official audit by identifying the areas that need special attention and sharing good practices necessary to successfully pass the process.

– Due to companies’ need to adapt to the changing IVDR regulations, we currently have a large number of inquiries in this area, including requests for preparing documentation related to medical standards or documentation audits. We are glad that we can better support existing and new customers in their challenges – says Wojciech Drescher, Head of the Healthcare Industry at Sii Poland.

Do you need support in the area of ​​ISO or GDPR? Contact our expert.

Wojciech Drescher

Head of Healthcare Industry

Contact our expert

Wojciech Drescher

Do you need support in the area of ISO or want to learn more about our solutions for the healthcare industry? Contact our expert

This field must contain only letters and special characters

Uploaded file:

  • danieltroc.pdf

Allowed extensions: DOC, DOCX, PDF (max 5MB)

Thank you for filling out the form.

We will look over your message and get back to you as soon as possible.

Sorry, something went wrong and your message couldn’t be delivered.

Please refresh the page and try again.

File upload error

No file was uploaded

Incorrect file size (max 5MB)

Invalid file format

Empty file

Processing…

You might also like

More news

Don't miss out

Subscribe to our newsletter and keep up to date with the latest news from Sii.

SUBMIT

Ta treść jest dostępna tylko w jednej wersji językowej.
Nastąpi przekierowanie do strony głównej.

Czy chcesz opuścić tę stronę?

Einige Inhalte sind nicht in deutscher Sprache verfügbar.
Sie werden auf die deutsche Homepage weitergeleitet.

Möchten Sie fortsetzen?