top of page

Medical Device Audit & Gap Analysis Assessments

Device Audits is a division of The Auditing Group and The Quality Groups.  We specialize in:

  • 'Due-diligence' and 'For-Cause' Audits and Gap Analysis, gauging your current operations.

  • Implementation, training and qualifications for your Quality Management System (QMS).

  • Audit and Gap Analysis supporting your Device Master Records, Design History Files, and your Device History Records.

  • Harmonization of your regulatory requirements with all applicable Federal Regulations and Conformance Standards.

  • Providing the Templates, Procedures, Manuals, Policies and Training to support all class of Medical Devices.

  • Audit and Qualification of Vendors, Suppliers, Contractors and Consultants.

​

  • 21 CFR Part 820 Quality Systems Regulations (and all predicate rules)

  • ISO 13485:2016 Quality Management System Audits

  • Combination Devices - Drug (Part 211) or Biologic (Part 610) Constituent

  • Medical Device Single Audit Program (MDSAP)

  • FDA 483's, Warnings & PMA/510(k) Registrations (GUDID Filing)

  • EU 2017/745 Medical Device Regulations

  • NMPA Decree 64 Chinese Medical Device

  • Health Canada CMDR (sor/98-282)

  • Brazil ANVISA

  • Japan MHLW Ordinance 169 

  • ISO 14971 Risk Management

  • Australian TGA​

CAPALogo3.jpg
483Help_TurnKey.jpg
TVG1.png
GMPBCLogo8White.jpg
GXPGroup.jpg

At Device Audits, The Auditing Group, and GMP Publications,

  • we know the Regulations,

  • we Audit the Regulations,

  • we conduct QMS Compliance training, and,

  • we assist Companies in complying with the Regulations

GMPLogoClean-16.jpg
Part820Noborder.jpg

We assist with Harmonization of your requirements: 

  • U.S. FDA, ISO 13485:2016 and EU 2017/745 Standards

  • Quality Management Systems and Data Integrity​

bottom of page