 Stratos Awarded ISO 13485 CertificationStratos has received ISO 13485:2003 certification, the internationally recognized quality standard for medical devices.
BSI Assurance Mark The certification is the result of an extensive assessment performed by BSI Group and it confirms that Stratos’ Quality Management System has been effectively implemented to the requirements of ISO 13485. As the medical device industry faces intensifying regulatory scrutiny over supplier qualification and control, manufacturers are increasingly motivated to engage development partners who are certified by recognized standards. Stratos’ proven track record of delivering safe and effective medical device designs to our clients is further bolstered by the achievement of this milestone. “Our team consistently implements efficient, ISO 13485 design controls and delivers high-value product solutions to our clients,” said CEO Allan Stephan. “This certification is a further confirmation that our product designs will meet regulatory requirements, allowing us to bring even more value to our clients.” About Stratos Product Development Since 1987, Stratos has been the trusted resource for science and technology innovators. Whether solving incredibly complex technical challenges, or bringing new market opportunities to fruition, our product designers and engineers can be counted on to deliver. Our collaborative, cross-discipline approach enables us to reduce time-to-market, maximize product opportunities and create compelling product solutions for users and unmet needs in the marketplace. Contact Stratos to take your next product idea from possibility to reality. End
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