Whitepapers

QMSR Compliance Deadline: February 2, 2026 | Medicept

Medicept — Mon, 24 Nov 2025 15:15:00 GMT

The FDA is implementing the new Quality Management System Regulation (QMSR), aligning requirements with ISO 13485 while introducing additional FDA-specific expectations for risk-based processes, documentation, and management accountability. Manufacturers will face deeper inspection focus, increased supplier oversight requirements, and a stronger emphasis on risk-based decision-making across every quality system process. Those beginning preparations now will be better positioned for QMSR readiness ahead of the February 2026 compliance deadline.

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Risk Management Series – Part 5: Assigning Harms and Severity | Medicept

cthomas — Tue, 20 May 2025 15:15:00 GMT

In part 5 of this ongoing white paper series, authors Gregg Van Citters and Brian Siroka dive into the next step in the risk management process, which is assigning harms and severity.

Whether you’re a seasoned professional or new to medical device risk management, this read offers valuable perspective and actionable advice.

Risk Management Series Introduction – Beyond FMEA | Medicept

cthomas — Tue, 05 Mar 2024 13:00:00 GMT

Are you looking to improve your risk management system? Having trouble ensuring you are complaint with ISO 14971:2019, IEC/TR 80002-1:2009 and other risk management standards? This MEDIcept White Paper is here to help.

This paper will serve as an introduction to an ongoing series of papers that will set out to provide tips on applying risk management principles and tools to improve the safety and performance of their devices and maintain compliance with risk management standards.

Introducing the first paper of this series, “Safety Risk Management Series Introduction – Beyond FMEA”, your gateway to a new and improved risk management system.

Implementing Cybersecurity Controls in Medical Devices | Medicept

cthomas — Mon, 27 Nov 2023 15:30:00 GMT

Are you interested in implementing cybersecurity controls in your medical devices? You’re in luck! This MEDIcept White Paper will discuss all things cybersecurity with a focus on quality system considerations and the content of premarket submissions.

Discover insights into the rapidly evolving landscape of cybersecurity in medical devices with the FDA guidance document, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.” In a world where medical devices are becoming increasingly interconnected, this document addresses the imperative need for robust cybersecurity controls, especially with the proliferation of wireless and network-connected capabilities.

Explore the comprehensive approach outlined by the FDA, emphasizing the significance of secure design and mitigation throughout a device's lifecycle. Learn about the groundbreaking Secure Product Development Framework (SPDF) and how the guidance aligns with international recommendations and new cybersecurity requirements introduced by the Consolidated Appropriations Act of 2023. Dive into the future of medical device cybersecurity and stay ahead of the curve in this rapidly evolving field!

Do you want to learn more about cybersecurity when it comes to your medical devices? MEDIcept has Quality Engineering experts who are here to help. Reach out to us today at sales@medicept.com.

FDA Guidance Documents for De Novo Classification | Medicept

Medicept — Wed, 29 Jun 2022 13:30:00 GMT

The De Novo classification process is a risk-based approach for classifying novel medical devices that had previously been automatically placed in Class III, the highest United States device classification.

On October 4, 2021, the US Food and Drug Administration (FDA) issued a final rule to set requirements for the medical device De Novo classification process. On October 5, 2021, FDA issued new versions of four Guidance Documents related to the De Novo Classification Process to align with the final rule. These Guidance Documents attempt to provide additional transparency regarding the De Novo classification process regarding user fees and refunds, expectations on content submission, and MDUFA review goals. This paper summarizes the content of each of the Guidance Documents.

White Paper - Transition Plan for COVID19 EUAs | Medicept

Medicept — Tue, 14 Jun 2022 14:00:00 GMT

White Paper on Transition Plan for Medical Devices that fall within enforcement policies and EUAs issued during the COVID-19 Public Health Emergency.

The FDA has provided their thoughts on 180-day transition plans to get back to standard practices (compliance with the Federal Food, Drug, and Cosmetic Act and regulatory requirements) for medical devices issued Emergency Use Authorizations (EUAs) or that fall within Enforcement Policies issued during the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. FDA will tell industry 180 days in advance of the planned termination of Emergency Used Authorizations or withdrawal of the enforcement policies. Manufacturers with devices placed on the market under the COVID-19-related enforcement policies or COVID-19 EUA declarations need to start planning for and working on the relevant submissions to FDA now, especially if they intend to continue distribution of their device(s).

Understanding Proposed 21 CFR 820.35 White Paper | Medicept

Medicept — Tue, 17 May 2022 20:00:00 GMT

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Medical Device Requirements in the FDA's Proposed QMSR | Medicept

Medicept — Tue, 17 May 2022 12:30:00 GMT

On Feb. 23, 2022, the U.S. FDA published the Draft Proposed Rulemaking for the new “Quality Management System Regulation.” It’s imperative that the entire industry thoroughly understand the new proposal and any nuances. This White Paper is Part 2 of a series of technical analyses to help inform any interested parties.

Definitions to Know in the FDA's Proposed QMSR | Medicept

Medicept — Fri, 04 Mar 2022 16:30:00 GMT

On Feb. 23, 2022, the U.S. FDA published the Draft Proposed Rulemaking for the new “Quality Management System Regulation.” It’s imperative that the entire industry thoroughly understand the new proposal and any nuances. This White Paper is Part 1 of a series of technical analyses to help inform any interested parties.

Understanding Definitions White Paper Download | Medicept

Medicept — Wed, 02 Mar 2022 13:30:00 GMT

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