This Week in Quality – February 9, 2026

The FDA Quality Management System Regulation took effect February 2 incorporating ISO 13485:2016. Singapore, GE Aerospace and partners established SPAARC for aviation technology research. Nvidia and Dassault Systèmes announced a strategic partnership for industrial AI. Kimberly-Clark and Kenvue shareholders approved the $48.7 billion acquisition. Hitachi Energy contracted with Trívia Trens for São Paulo railway modernization.

FDA Quality Management System Regulation Takes Effect February 2

The FDA Quality Management System Regulation (QMSR) took effect February 2, 2026, replacing the Quality System Regulation (QSR) under 21 CFR Part 820 and incorporating ISO 13485:2016 by reference to harmonize U.S. medical device manufacturing requirements with international standards. The regulation modernizes oversight for manufacturers marketing finished devices in the United States.

The QMSR reduces Part 820 from 15 sub-parts to 2 sub-parts while maintaining current good manufacturing practice requirements and integrating risk management throughout quality systems. The transition requires manufacturers to update quality systems and documentation to comply with the international standard and FDA’s additional requirements beyond ISO 13485:2016.

Singapore, GE Aerospace Launch SPAARC Partnership for Aviation Research

The Civil Aviation Authority of Singapore, Singapore Economic Development Board, GE Aerospace and International Centre for Aviation Innovation signed a memorandum of understanding February 2, 2026 establishing the Singapore Partnership for Aviation & Aerospace Research and Capability (SPAARC) focused on next-generation aviation technologies across AI applications, airspace modernization, advanced aerodynamics and propulsion systems. The partnership operates as a distributed research unit leveraging Singapore’s regulatory framework and relationships with FAA and EASA.

GE Aerospace expands beyond its existing maintenance, repair and overhaul operations in Singapore, which accounts for over 60% of its global repair volumes and serves as the first MRO site globally to use additive manufacturing for commercial jet engine component repairs. The collaboration positions Singapore as a global hub for aerospace innovation complementing operational activities at Singapore Changi Airport with upstream research and development capabilities.

Nvidia, Dassault Systèmes Build Industrial AI Platform with Virtual Twins

Nvidia and Dassault Systèmes announced February 3, 2026 a long-term strategic partnership to establish a shared industrial AI architecture combining Dassault’s virtual twin technologies with Nvidia’s AI infrastructure, open models and accelerated software libraries across biology, materials science, engineering and manufacturing sectors. The partnership will deploy science-validated industry world models through Dassault’s 3DEXPERIENCE platform serving over 370,000 customers globally.

Dassault Systèmes will deploy AI factories using Nvidia infrastructure on three continents through its OUTSCALE brand, while Nvidia adopts Dassault’s model-based systems engineering to design AI factories starting with the Nvidia Rubin platform. The collaboration integrates Nvidia BioNeMo for molecular discovery, SIMULIA AI-based physics behavior using Nvidia CUDA-X libraries and Nvidia Omniverse physical AI libraries for autonomous software-defined production systems.

Kimberly-Clark, Kenvue Shareholders Approve $48.7 Billion Acquisition Deal

Kimberly-Clark and Kenvue shareholders voted January 29, 2026 to approve Kimberly-Clark’s acquisition of Kenvue with 96% of shares present at Kimberly-Clark’s special meeting and 99% of votes at Kenvue’s special meeting representing 77% of outstanding Kenvue shares. The $48.7 billion cash and stock transaction will create a $32 billion combined company expected to close in the second half of 2026.

The acquisition combines Kimberly-Clark brands including Huggies, Kleenex and Depend with Kenvue brands including Tylenol, Band-Aid, Listerine and Neutrogena. Current Kimberly-Clark shareholders will own approximately 54% and current Kenvue shareholders will own approximately 46% of the combined company on a fully diluted basis with anticipated run-rate synergies of $2.1 billion.

Hitachi Energy Partners with Trívia Trens on Brazil Railway Modernization

Hitachi Energy signed a contract with rail concessionaire Trívia Trens to provide power supply for Lines 11, 12 and 13 of the Metropolitan Trains in São Paulo serving 1.3 million passengers daily. The concession includes investments of approximately $2.66 billion over 25 years and modernization and expansion of over 120 kilometers of railway tracks across the Alto Tietê Lot.

Hitachi Energy will deliver high-voltage grid connections and direct current electrical infrastructure including rectifiers and DC switchgear building on its acquisition of COET, a designer and manufacturer of power solutions for rail and electric mobility. The project will enhance operational reliability and support sustainable urban mobility transformation in São Paulo, the most populous city in the Americas with approximately 21.6 million people in the metropolitan region.