FDAは1980年代から『設計管理』について厳しい規制をかけてきた。
その理由は、医療機器はたとえ製造所で図面に従って適切に製造したとしても、そもそも設計が間違っていたら安全な医療機器にならないからである。
現状では市場における不具合の約50%が設計問題であり、そのうちの90%までもがソフトウェアの不具合である。
ところで筆者がコンサルテーションをする中で、医療機器企業の設計部門が『設計管理』について勘違や誤解または知らないということが多々ある。
『設計』と『設計管理』は異なる
まず『設計』と『設計管理』は異なると言うことである。
FDAやISO-13485が要求（規制）しているのは、『設計』ではなく『設計管理』である。
当然のことながら『設計』が出来なければ製造が出来ないわけで、各社は必ず『設計』を実施している。
どのように仕様書を作成するか、どのように図面をひくかといった『設計』行為に関しては規制要求はない。
したがって、しばしば設計書の書き方、仕様書の書き方、検証計画書の書き方などを質問されるが、言ってみればそれらは自由である。
しかしながら設計開始時には設計開発計画書を作成し、設計の各段階において設計開発計画書を遵守して『設計管理』を実施することは規制要件や国際規格で要求されている。
しかしながら現状においては、多くの医療機器企業において『設計管理』が不適切であると思われる。
設計開発計画書では設計へのインプットを定義し、『設計』のどの段階でどのようなデザインレビュを誰が実施するのかなどを詳細に記載しておかなければならない。
適切かつ詳細な設計開発計画書の作成が行われておらず、また設計開発計画書の改訂も適切に実施されていない。
また設計開発計画書の遵守も適切に実施されていない。
なお、クラスIの医療機器のほとんどは『設計管理』の適用を受けない。ただし、ソフトウェアを搭載している場合は『設計管理』の適用を受けるので注意が必要である。
『設計』の目的は『製造できるようにする』ことである
次に『設計』の目的は『製造できるようにする』ことである。
これは自明であろう。つまり製造するために『設計』するのであるから、『工程設計』も『設計』に含まれるのである。
したがって『工程設計』に関する記録類もデザインレビュにかけ、DHF（設計開発ファイル）に保存しておかなければならない。
『設計管理』において設計変更が重要であるが、いわば設計変更は製造変更である。別の言い方をすれば、製造を変更しない設計変更はあり得ないのである。
『ラベリング』も設計からのアウトプットである
『ラベル』や『ラベリング』も設計からのアウトプットであり、デザインレビュの対象であり、その記録はDHF（設計開発ファイル）に保存しておかなければならない。
ここで『ラベル』は『ラベリング』の一種である。
『ラベリング』とは、患者やユーザが目にするあらゆる印刷物を言う。
例えば、『ラベリング』に含まれるものは、取扱説明書（簡易取説等を含む）、添付文書、包装表示、サービスマニュアル、トレーニング用資料、カタログ、展示会用資料、ホームページ、製品紹介用ビデオ等である。
これらは適切に設計され、レビュされ、承認されなければならない。
ただしここで切り分けが困難なのは、どこまでがAdvertisement（宣伝）でどこからが『ラベリング』であるかということである。
品番や価格を記載しているのみではAdvertisement（宣伝）であろう。しかしながら効能・効果をうたっていれば間違いなく『ラベリング』である。
患者・ユーザの目に触れる印刷物で『ラベリング』に相当しないものは、例えば送り状などがある。
『梱包材』も設計からのアウトプットである
『梱包材』も設計からのアウトプットである。したがって適切に『設計管理』が実施され、デザインレビュを実施し、その記録はDHF（設計開発ファイル）に保存しておかなければならない。
精密機械等の場合、特に『梱包材』の設計は重要である。
適切にバリデーションを実施し、輸送中の衝撃、振動などから機器を守るような緩衝材・梱包材になっていなければならない。
例えば、90cmの高さから梱包した製品を落下させてみるといったバリデーションテストなどである。
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