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Lemberg Solutions Receives ISO 13485:2016 Certification for Medical Devices and Quality Management Systems

Lemberg Solutions is excited to announce the achievement of ISO 13485:2016 standard, which encompasses internationally recognized regulations for medical devices and quality management systems. We have implemented the policies that comply with ISO 13485:2016 to deliver medical solutions on the highest quality.

Lemberg Solutions completed a surveillance audit for ISO 13485:2016 and obtained the certification on May 12, 2023. An auditor approved our policies and development flows as corresponding to internationally accepted standards. ISO 13485:2016 certification means we provide medical software and hardware solutions that comply with international healthcare regulations.

Lemberg Solutions applied for Class I medical devices with low risk of harming users, which are basically simple equipment validated by general controls. As a company that already complied with ISO 9001:2015 and ISO 27001:2013 standards, we were almost there to pass the audit since our existing certifications covered a large part of the ISO 13485:2016 requirements.

Here’s how Ros Bulych, CEO at Lemberg Solutions, comments on this accomplishment:

Lemberg Solutions’ credibility earned ISO 13485:2016 certification through the years of building our expertise in the healthcare industry. Receiving this certification means that our embedded engineering team can guarantee successful project development on an internationally recognized level of quality. Our company plans to invest in and grow healthcare competence, delivering and contributing to telemedicine and biotech innovative products.

Lyubomyr Dutko, CTO at Lemberg Solutions, about ISO 13485:2016:

ISO 13485:2016 is one of the essential certifications for healthcare software development, and our company viewed it as an opportunity to validate our technological proficiency. We are always ready to embrace new challenges to provide our clients with first-class product development.

We are looking forward to the future opportunities that ISO 13485:2016 certification will open to us. Now that we have officially confirmed our compliance with international standards, our clients can trust us even more with healthcare project delivery. Contact us to discuss your business needs.

About Lemberg Solutions

Lemberg Solutions is a tech consulting and engineering company that creates IoT products, Digital experiences, and AI solutions. With more than 300 clients from Europe and North America and 15 years of experience, we’ve delivered 800 hardware and software solutions.

About ISO 13485:2016

ISO 13485:2016 indicates requirements for a quality management system (QMS) for medical device manufacturers who must prove their competence in developing healthcare solutions that meet regulatory standards, ensuring product safety and quality. ISO 13485:2016 helps us grow our expertise and expand our services into the healthcare industry. Following the regulations stated in ISO 13485:2016, we ensure high-quality and secure project development.

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