Bagaimanakah Badan Penilaian Pematuhan (CAB) menangani situasi di mana peranti perubatan dihasilkan oleh pihak ketiga (OEM atau pengilang kontrak) bagi pihak pengilang? | How do Conformity Assessment Bodies (CABs) address situations where a medical device is manufactured by a third party (OEM or contract manufacturer) on behalf of the manufacturer?

CAB boleh menilai sistem pengurusan kualiti dan proses kedua-dua pengilang dan pengilang pihak ketiga (OEM atau pengilang kontrak) untuk memastikan pematuhan dengan keperluan-keperluan undang-undang.

 

CABs may assess the quality management system and processes of both the manufacturer and the third-party manufacturer (OEM or contract manufacturer) to ensure compliance with regulatory requirements.