ISO 13485:2016 Medical Devices Management
Remote Consultation

Pathfinder Package
ISO 13485:2016

Advocate Package
ISO 13485:2016

Collaborator Package
ISO 13485:2016

What comes in the Remote Consultation Packages?
Each package offers an increasing amount of input from the consultant, for persons who buy one of out DIY ISO solutions, there is a free pathfinder session included. Remote ISO consultation can be carried out over Skype, Team Viewer or Zoom (does not require install of software – browser based).
Many of our customers start off with a kickstarter package and then at a later date choose either an intermediate level consultation or the full day assistance, depending on their confidence level.
Pathfinder Package
ISO 13485:2016
Detailed explanation of the requirements of ISO 13485
Identifying and documenting key processes

Advocate Package
ISO 13485:2016
Detailed explanation of the requirements of ISO 13485
Risk Assessment of Medical Devices
Identifying and documenting key processes
Contents of a technical file

Collaborator Package
ISO 13485:2016
Detailed explanation of the requirements of ISO 13485, 2016
Identifying and documenting key processes
Risk Assessment of Medical Devices
Implementing and Certifying an Effective Management System
Contents of a Technical File
Setting targets for ongoing system improvement

Need Options?
If you have arrived at this page directly from a search engine and you would prefer another means of approaching the implementation of ISO 13485:2016 for your business, we offer either direct face to face consultation or as an alternative (reduced budget) remote web based consultation.
Face to Face Consultation

DIY With Training
