{"id":48999,"date":"2021-09-16T08:48:35","date_gmt":"2021-09-16T08:48:35","guid":{"rendered":"https:\/\/sii.pl\/?p=48999"},"modified":"2023-09-14T14:28:48","modified_gmt":"2023-09-14T14:28:48","slug":"quality-in-every-area-sii-poland-supports-the-manufacturing-process-of-medical-devices-with-the-iso-13485-certificate","status":"publish","type":"post","link":"https:\/\/sii.pl\/en\/news-feed\/quality-in-every-area-sii-poland-supports-the-manufacturing-process-of-medical-devices-with-the-iso-13485-certificate\/","title":{"rendered":"Quality in every area – Sii Poland supports the manufacturing process of medical devices with the ISO 13485 certificate"},"content":{"rendered":"

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 <\/strong>\u2013 ISO 13485: 2016 <\/strong>\u2013 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.<\/strong><\/p>\n\n

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For many, the ISO 13485 standard is associated only with the production of specific medical equipment or pharmacological products.<\/p>\n\n

\u2013 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 \u2013 explains Piotr Mazurski, Senior Security Specialist at Sii Poland<\/strong>.<\/p>\n\n

Comprehensive services for the medical industry<\/h2>\n\n

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.<\/p>\n\n

\u2013 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 \u2013 says Sebastian Pyzik, Compliance Security Department Manager at Sii Poland<\/strong>.<\/p>\n\n

Support in preparation for the audit<\/h2>\n\n

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.<\/p>\n\n

\u2013 Due to companies\u2019 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 \u2013 says Wojciech Drescher, Head of the Healthcare Industry at Sii Poland<\/strong>.<\/p>\n\n

Do you need support in the area of \u200b\u200bISO or GDPR? Contact our expert.<\/p><\/div><\/section>

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Wojciech Drescher<\/h2>\n

Head of Healthcare Industry<\/h2>\n \n Contact our expert<\/span>\n <\/a>\n <\/div>\n <\/div>\n <\/div>\n\n <\/div>\n
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Wojciech Drescher<\/h2>\n