October 2014 - MEDIcept

Risk Management Series – Part 2: Prioritizing Risk Management Activities [UPDATED]

Oct 30, 2014 | Documents, Risk Management

Medical Device Risk Management Series – Part 2: Prioritizing Risk Management Activities This second article in our series addresses a common risk analysis problem – prioritization. In large medical device companies, the email invitation to a Failure Mode...

Risk Management Series Introduction – Beyond FMEA [UPDATED]

Oct 30, 2014 | Documents, Risk Management

Risk Management White Paper Download MEDIcept is presenting this paper as an introduction to an ongoing series of articles focused on the conduct of risk management in the medical device industry.

Health Hazard Analysis Tips

Oct 14, 2014 | News

Health hazard analyses (HHAs) are a necessary part of the medical device manufacturing process since the FDA revised Medical Device Good Manufacturing Practices Regulation, 21 CFR Section 820 in 1996. They were replaced with the Quality System regulations and included...

Harmonization of the Quality System Regulation

In May 2018, the FDA first proposed revising its current Quality System Regulation (QSReg) to better align with ISO 13485:2016. The QSReg is the foundation rule for manufacturing safe and effective medical devices to be sold in the US, while ISO 13485 forms the basis for quality systems compliance with regulators in a variety of countries outside the US. The problem, however, comes from the fact that the FDA still hasn’t published a draft of its revised QSReg. The FDA has already missed three...

FDA Restarting Domestic Inspections

On July 10, 2020, the U.S. Food and Drug Administration (FDA) stated their plan on restarting onsite domestic inspections. In March, FDA had reduced inspections due to the COVID-19 pandemic, and they have only been conducting mission critical inspections over this period. FDA Commissioner Stephen Hahn said in a statement that FDA is “working toward the goal of restarting on-site inspections during the week of July 20.” A new COVID-19 Advisory Rating System is being employed in order for the...

Electronic Submissions For Medical Devices

On July 15, 2020, FDA released a guidance regarding electronic submissions for medical devices as well as the FDA’s plans for implementing section 745A(b)(3) of the FDA Reauthorization Act of 2017 (FDARA). The FDA has stated that additional details will be laid out in future related guidance documents. The released guidance in July follows a draft issued in September 2019. The guidance outlines the submissions that must be sent to FDA electronically via the eSubmitter and which may still be...