To achieve medical Device Interoperability, system boundaries need to be defined, system architecture needs to be aligned, and interfaces and communication protocols need to be established across individual components of the medical device. In some cases, it is as important to design and implement QMS Interoperability as it is to design Device Interoperability.
Navigating the conformity assessment process – examination of a manufacturer’s technical documentation and quality management system – requires a thorough understanding of the different routes and options available for various risk classifications of medical devices and IVDs, while knowledge of the conformity assessment process helps manufacturers prepare effectively and manage expectations. This blog offers guidance for creating successful conformity assessments.
IVDR has significant implications for the manufacturing of IVD devices, as it requires manufacturers to comply with new and more rigorous regulatory requirements. Wiktoria Banczyk, Product Manager Lab Filtration Medical Devices at Sartorius Lab Instruments, discusses the challenges posed by the implementation of EU IVDR 2017/746 and key considerations for manufacturers as they navigate today’s regulatory landscape.
John Taylor has 30 years of software development and senior leadership experience. Prior to joining ETQ in 2018, he was senior vice president with PTC.
With only one month until the compliance deadline, many medical device companies still have much to prepare in order to meet the requirements.
A discussion with Geoff Wood about the advantages offered by having a pre-assessment before a Stage 1 and 2 Initial Audit.
CAPA consistently remains a top reason for FDA’s 483 observations, usually due to inadequate processes or inconsistent adherence to regulatory requirements.
With digitalization impacting all areas of manufacturing operations, it should come as no surprise that medical device producers must adapt or risk missing the next wave of performance and product improvements.
Although the full impact of COVID-19 is uncertain, one sure thing is that industry continues to crave information to help them navigate EU MDR.
Although medical device manufacturers have more time to prepare due to the delayed EU MDR deadline, this shouldn’t distract from the extensive documentation they must compile in the meantime to prove their devices are compliant.