Let’s imagine that your medical device company, headquartered in Nurnberg, Germany, has designed an innovative and award-winning, extended vision foldable, presbyopia-mitigating, intraocular lens (IOL) for use by patients undergoing cataract surgery. This device will...
The tough part for the medical device industry is that this landscape of regulations is constantly changing, and therefore, intimidating. The European Union’s Medical Device Regulations (EU MDR) which came into effect on 26 May 2021 after a three-year transition...
ISO 13485 is an internationally recognized Quality Management System (QMS) standard for the medical device industry. Meeting the requirements of ISO 13485 Quality Management System (QMS) demonstrates a commitment to quality and customer satisfaction, which is...
The ICH Q10 pharmaceutical quality system document is an all-inclusive manuscript that serves as a model for an efficient quality management system (QMS) in the pharmaceutical industry. By implementing the ICH Q10 pharmaceutical quality system you will demonstrate to...
Current Good Manufacturing Practice (cGMP) is a set of regulations that was initially put forth by the FDA to ensure that business organizations, manufacturers, and packagers of pharmaceutical products, medical devices, blood, and certain foods proactively guarantee...
It’s quite easy to mix up the Failure Mode and Effects Analysis (FMEA) from IEC 60812:2018 and the Hazard Traceability Matrix (HTM) in the ISO 14971:2019. Especially since nothing prevents a company from using these terms interchangeably or using different terms...
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