厚生労働省は、2021年3月26日付で「医療機器及び体外診断用医薬品の製造管理及び品質管理の基準に関する省令の一部を改正する省令」（令和３年厚生労働省令第60号）を公布しました。
施行期日は2024年3月26日です。（改正省令の施行の日から起算して３年を経過する日）
今回の改正の趣旨は、QMS省令と医療機器の品質マネジメントシステムの国際規格であるISO13485:2016と整合を図ることです。
改正前のQMS省令はISO13485:2003年版と整合させており、最新の国際規格からは遅れていました。
医療機器製造版業者は改正QMS省令に準拠したQMSの構築を施行後3年以内に実施する必要があります。
改正QMS省令の元となるISO-13485:2016は、米国FDA QSR（21 CFR Part 820）に極めて近く、特に設計管理について詳細な要求が盛り込まれています。
例えば、設計・開発ファイルの作成や設計移管が追加になりました。
医療機器は、たとえ設計された図面の通り適切に製造したとしても、そもそも設計に間違いがあった場合、安全な医療機器とはならないためです。
またQMSで使用するソフトウェアに関するバリデーション（CSV：Computerized System Validation）も新たに要求されました。 さらに設計ベリフィケーション、設計バリデーション等においてサンプリングの根拠となった統計的手法を説明しなければなりません。 苦情処理に関しては、タイムフレームが設けられ、サービスレポート（修理報告書）からも苦情を抽出しなければなりません。 またサービスレポートも統計的手法の対象となります。
本セミナーでは、従前のQMS省令と改正QMS省令を比較し、要点と留意すべき点などを分かりやすく整理して3時間で解説いたします。
また、改正QMS省令のポイントと、対応するためのQMS構築方法を具体例とともにわかりやすく解説いたします。
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[blogcard url=”https://ecompliance.co.jp/SHOP/QMS-MHLW-00.html” title=”【2021年度改正QMS省令対応】QMSひな形一式” content=”すでに現行QMS省令に準拠したQMSを構築されているが改正対応が必要な企業、これから医療機器に参入する企業にオススメのひな形セットです。”]
[blogcard url=https://xn--2lwu4a.jp/qms-md/ title=”QMS（手順書）ひな形 医療機器関連” ]
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In 2023, Roblox released public beta versions of the platform for Quest 2 and Meta Quest Pro on July 27, with full versions released in September. Throughout 2021, Roblox averaged 45.5 million daily active users, a 40% increase from the end of 2020. It was removed due to the company believing newer players would get confused by the presence of two separate currencies. The company also expressed interest in porting Roblox to other virtual reality devices in the future.
Additionally, in 2019, Roblox released Roblox Premium, which replaced its previous Builders Club memberships. In April 2016, Roblox became available for Oculus Rift, alongside a variety of quality-of-life features made specifically for that platform. In August 2019, Roblox began allowing select users to upload their own accessories, a service that was later expanded to include various other types of accessories. The platform’s growth was further accelerated by the COVID-19 pandemic beginning in 2020, where lockdowns led tens of millions of children to use Roblox as a means of communication. This also came with a feature called Smooth Terrain, which increased the graphic fidelity of in-game terrain.
Features that were introduced around this time included Developer Events, a service that would allow creators to create and manage in-game events, and allow users to easily discover these events. On December 11 of that year, a full version of Roblox for iOS was released that allowed users to play games, although users were not able to use Roblox Studio. Baszucki and Cassel worked alone while making the earlier versions of Roblox, and created their own games on the platform before the creation tools were completed. Due to its status as a user-created games platform, Roblox has a variety of popular games; by July 2020, at least 20 games had been played more than one billion times, and at least 5,000 have been played more than one million times. While only Roblox developers were able to create avatar items early on, the capabilities of user-generated content has expanded greatly over time.
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In September 2016, after introducing an enhanced notification system to inform users of these violations, YouTube’s policies were criticized by prominent users, including Philip DeFranco and Vlogbrothers. YouTube Play Buttons, a part of the YouTube Creator Rewards, are a recognition by YouTube of its most popular channels. In April 2017, YouTube set an eligibility requirement of 10,000 lifetime views for a paid subscription. Usually, no more than half of the eligible videos have a pre-roll advertisement, due to a lack of interested advertisers. According to TubeMogul, in 2013 a pre-roll advertisement on YouTube (one that is shown before the video starts) cost advertisers on average $7.60 per 1000 views. Google stated that it had “begun an extensive review of our advertising policies and have made a public commitment to put in place changes that give brands more control over where their ads appear”.
In 2014, YouTube announced a subscription service known as “Music Key”, which bundled ad-free streaming of music content on YouTube with the existing Google Play Music service. Most of these views came from a relatively small number of videos; according to a software engineer at that time, 30% of videos accounted for 99% of views on the site. By 2010, the company had reached a market share of around 43% and more than 14 billion views of videos, according to comScore. Despite its growth and success, the platform has been criticized for its facilitation of the spread of misinformation and copyrighted content, routinely violating its users’ privacy, excessive censorship, endangering the safety of children and their well-being, and for its inconsistent implementation of platform guidelines. YouTube incorporated the Google AdSense program, generating more revenue for both YouTube and approved content creators.
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