Regulation and standards - Garza MD

Garza MD has extensive knowledge of and experience with the following regulation and standards:

• MDD 93/42/EEC (Medical Device Directive)
• MDR 2017/745 (Medical Device Regulation)
• CMDR SOR/98-282 (Canadian Medical Device Regulation)
• FMD 2011/62/EU (Falsified Medicine Directive)
• GDPR 2016/679 (General Data Protection Regulation)
• TGMDR 2002 (Australian Therapeutic Goods Regulations)

• ISO 13485 – Quality Management Systems
• ISO 9001 – Quality Management Systems
• ISO 14971 – Risk Management
• IEC 62366 – Usability
• ISO 62304 – Medical Device Software Life Cycle
• GAMP 5 – Risk based computer systems validation
• IEC 60601-1 – Electrical Safety of Medical Equipment
• ISO 27001 – Information Security Management Systems