SafeOp Surgical Provides Innovative Monitoring Tools
SafeOp Surgical Provides Innovative Monitoring Tools
SafeOp Surgical, Inc
SafeOp Surgical, Inc

Regulatory Information

QUALITY MANAGEMENT SYSTEM

ISO 13485 quality system certification

US FDA Good Manufacturing Practice (GMP) 

We are fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations. View our Establishment Registration on the FDA website

 

NOTIFIED BODY / REGISTRAR / CERTIFICATION BODY

SafeOp Surgical, Inc. maintains ISO 13485:2003 certification and is audited by:

 

SGS
1 Place des Alpes
P.O. Box 2152
1211 Geneva 1
Switzerland

(Certificates US15/842472 and US15/842471)

 

ISO Certification SafeOp Surgical
SafeOp_13485_Cert.pdf
Adobe Acrobat document [635.7 KB]
MDD Certification SafeOp Surgical
SafeOp Surgical_606695_V1_MDD Cert issue[...]
Adobe Acrobat document [182.2 KB]

Contact Us Today!

SafeOp Surgical Inc
11350 McCormick Rd. 

EP III, Suite 1003

Hunt Valley, MD 21031
Phone: 844-723-3677

E-mail: info@safeopsurgical.com

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