医療機器の「設計」と「設計管理』の違いについて
筆者がコンサルテーションを実施していて、設計管理について多くの方々が勘違いしていることがある。
規制要件や国際規格（ISO-13485）などが要求しているのは、『設計管理』であって『設計』そのものではないのである。
『設計』は各社のやり方に従って図面を描き、仕様書を作成すれば良いだろう。
『設計管理』ではQMSを遵守（例：DRの実施など）し、必要な文書・記録をDHF（設計履歴ファイル）に保存しなければならない。
ファイルとは
ISO-13485やその他の国際規格では「ファイル」というものの作成が多く求められている。
例えば「DHF（デザインヒストリーファイル：設計開発ファイル）」「RMF（リスクマネジメントファイル）」「ユーザビリティファイル」などである。
そもそも「ファイル」の目的は、第三者認証機関が規格毎に監査しやすいように関連した文書・記録をまとめておくためのものである。
そうしなければ、膨大な設計文書・記録から当該文書・記録を探し出すのに手間がかかってしまう。
しかしながら、DHFとRMFとユーザビリティファイルはお互いに重なり合っていて、また文書・記録も区別されていない。
そこで一般的には、「ファイル」においては目録を作成し、トレーサビリティチャートによって、どの記録の何章が当該記録に相当するのかをポイントすることとなる。
くれぐれも「ファイル」という記録を作成する訳ではないので注意が必要である。
設計のゴールとは
医療機器の場合は、設計のゴールは2つある。
・申請資料を作成する
・製造できるようにする
特に設計者は薬事申請のことを知らずに設計文書を作成してしまう。
申請書を作成する段階になって、慌てて申請戦略と整合性をとろうとしても手遅れである。
また検証とバリデーション（V&V）に関するデータが足りず、申請資料（STED）が書けないため、追加で実施することにもなってしまう。
申請戦略を早い目に共有し、申請資料（STED）の作成方法についても知っておく必要がある。
また量産できなければ設計は終了しない。設計が変更になると必ず製造方法も変更になってしまう。
したがって多くの場合は「設計変更」ではなく「製造変更」なのである。
設計者は上記の2点をよく理解して医療機器を設計しなければならない。
【お知らせ】
イーコンプライアンスでは、ISO-14971:2007対応QMSひな形を販売しております。
リスクマネジメント規程・手順書・様式
また各種QMSのひな形を販売しております。詳細はこちら
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