Resources

Omnex Resource Center

Filter (0) Filter (0)

216 items Found

	Update to APQP and PPAP Standard Demanding Space and Defense Industry requirements for Quality Management requires a fresh look at best practices. Publish Date:November 16, 2023

	Revision of the AS9100 and Other Aerospace Standards In this presentation, we will cover: Brief Background of IAQG, AS9100 Status, AS9145 Status, Revisions to SCMH, New Aerospace Standards on the Horizon. Publish Date:November 16, 2023

	Information Security – ISO 27001 The ISO/IEC 27001:2022 standard provides the requirements for an Information Security Management System (ISMS) as well as a listing of best practice information and cybersecurity controls (IC/ICC), contained in Annex A of the standard. Publish Date:November 16, 2023

	Quality Culture – ISO 10100 ISO (the International Organization for Standardization) published, ISO 10010:2022 (First Edition), an international standard for providing guidance on the evaluation, development and improvement of organizational quality culture to help an organization to achieve sustained success. Publish Date:November 16, 2023

	DevOps and Safety? SafeOps! – Towards Ensuring Safety in Feature-Driven Development with Frequent Releases The increasing importance of software and the rising level of connectivity of safety-critical products such as vehicles enable continuously improving and adding the functionality. DevOps development principles support such kind of continuous deployment. However, safety-critical products shall fulfil Publish Date:November 14, 2023

	Recent Developments in IMDRF Standards including Cybersecurity The presentation will discuss who the IMDRF is what they do and the developments in the industry with the FDA on the Cybersecurity forefront. It will also discuss some of the frequently asked questions when considering Cybersecurity with new submission and what can be expected now. Publish Date:November 14, 2023

	ISO 62304 – Software Life Cycle Processes, the Challenges for Medical Devices Following an introduction of the company (Ametek/Rauland) and its products, the presentation provides a brief description of the journey Rauland, a medical device company and a leader in healthcare and education communication systems, is on to continue to strengthen its level of compliance with ISO- Publish Date:November 14, 2023

	Model Based Design and Digitalization The business environment has changed in the last 20 years while organizations have not. In most of the companies Omnex works with employees are running the business with email, spreadsheets and one point solutions. Publish Date:November 10, 2023

	Cybersecurity Mandates for Medical Devices Medical Devices are increasingly connected in networks, cloud and to the internet. Publish Date:November 10, 2023

	FDA’s Proposed Changes to 21 CFR 820 21 CFR 820 contains the FDA’s requirements for Quality Management Systems. These requirements have been around a long time (since Jul 1978). FDA is now proposing to amend this regulation to align more closely with QMS requirements used by other global regulatory authorities. Publish Date:November 10, 2023