FDA Issues New Draft Guidance on Medical Device Quality System Software Assurance
21 CFR 820, the regulation that outlines the quality management system requirements for medical devices manufactured or distributed in the US, defines requirements for production and process controls in sec. 820.70 to ‘ensure that a device conforms to its specifications, with 820.70(i) listing the only requirements for software validation in automated processes, something that has […]
TC 210 Not Ready to Adopt Definition of Risk Outlined in Annex SL
Last week, we wrote about recent reflections on the current state of ISO 9001 and how the 2015 standard caused so much confusion with the added notion of risk-based thinking – how the standard failed to align with language in ISO 31000, while also acknowledging that the language in ISO 31000, as lauded as it […]
Recognition of EN ISO 14971 as a harmonized standard in support of the European Medical Device Regulations
Back in June, it was reported by TC 210, the committee responsible for medical device standards such as ISO 14971 and ISO 13485, that the European standard EN ISO 14971:2019 with its amendment A11:2021 had finally been cited in the Official Journal of the European Union (OJEU) as a harmonized standard in support of the […]
FDA Virtual Inspections Are Here to Stay – And That’s a Good Thing
The FDA may be easing from its pandemic response mode, but, like any industry and nearly every organization, two years of pandemic have normalized remote work for the agency and forced improvement in remote inspections. The FDA announced during the annual Drug Information Association (DIA) meeting on June 22nd that they do not plan to […]
The FDA Poses ‘Seven Questions’ to Begin Clarifying Details of the QSR Harmonization with ISO 13485
Last week we reported the breaking news that the FDA, after years of attempts and delays, had finally released the proposed rule to harmonize the current Quality System Regulation (QSR) outlined in 21 CFR 820 with the international standard for medical device quality management system requirements, ISO 13485:2016 to generate a new resulting regulation called […]
After Years of Delays, FDA Finally Issues Proposed Rule to Harmonize QSR to ISO 13485
After four long years and constantly slipping timelines, the FDA is finally making good on efforts to harmonize its Quality System Regulation (QSR), defined in 21 CFR 820, with the international standard for medical device quality management systems, ISO 13485, with a proposed rule issued Tuesday, 2/22/2022, with the resulting regulation being dubbed the Quality […]
Is My Product a Medical Device?
Is My Product a Medical Device? I get asked this question quite a lot. It’s important to understand the criteria of what constitutes as a medical device and how medical devices are classified so that the proper regulatory pathway is taken for pre-market clearance or approval, as well as saving yourself the trouble of going […]
Free Whitepaper: How Can ISO 13485 Help Your Business Grow?
If you’re in the business of developing and manufacturing medical devices, then “risk” and “risk management” have become terms synonymous with your daily operations. Your most important and critical responsibility is to bring a medical device to market that provides a needed function to a patient or consumer and is also proven to be safe […]
Free Whitepaper: Checklist of Mandatory Documentation Required by ISO 13485:2016
The latest version of ISO 13485 was published in 2016, which means medical device companies need to transition from the previous version of the standard and comply with the new requirements. One of the most important steps in the transition process, as well as in the initial implementation, is determining what documents and records are […]