ISO 13485:2016 Medical Devices Management
Remote Consultation
Remote consultation from ISO consultants offers business owners and project managers a cost effective means to implementing controls and policies neccessary for a business to become ready for an inspection.
Pathfinder Package
ISO 13485:2016
The pathfinder session is designed as directional overview to the processes and procedures required for a business to begin the integration of standards and the adherence to control policy documentation.
Advocate Package
ISO 13485:2016
This is a 3 hour session that allows our consultants to peform an analysis of your business and then to make meaningful recommendations to help you implement the controls for the standard.
Collaborator Package
ISO 13485:2016
A package that offers an entire day’s worth of consultation (upto 7 hours). The program allows the consultant to develop a more indepth appraisal of your business going on to produce a more defined set of directives for you to follow.
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
ISO 13485 is a standard defining the requirements of a quality management system to cover the design, manufacture and servicing of medical devices. Based on ISO 9001, ISO 13485 has additional requirements and is tied into ensuring compliance with the European and Worldwide Medical Device Directives.
Detailed explanation of the requirements of ISO 13485
Based on ISO 9001, ISO 13485 introduces additional requirements and is a much more demanding standard to implement. This session explains some of the additional requirements.
Identifying and documenting key processes
Setting and delivering against meaningful objectives
Advocate Package
ISO 13485:2016
The additional time given in the intermediate session allows us to focus in on more difficult requirements, such as risk assessment and the relationship with ISO 14971. Technical Files, by their nature, need to be complex and fairly lengthy. Structuring them for ease of maintenance, and ensuring their ongoing compliance are covered in detail, as key focal points of more third party certification visits.
Detailed explanation of the requirements of ISO 13485
Based on ISO 9001, ISO 13485 introduces additional requirements and is a much more demanding standard to implement. This session explains some of the additional requirements.
Risk Assessment of Medical Devices
Explaining the relationship with ISO 14971 and covering simplified methods of meeting both standards requirements.
Identifying and documenting key processes
Setting and delivering against meaningful objectives
Contents of a technical file
Maintaining the correct records
Collaborator Package
ISO 13485:2016
The Collaborator session can be used a single extended tutorial, giving a detailed explanation of the ISO standards requirements, used as a lengthy question and answer session where your unique issues can be discussed, or split into two sessions, perhaps with the first at the beginning of an implementation and the second as the project is nearing certification.
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
Working at your business premises along side you, we will guide you through the implementation of policies and controls that will ultimately make your company ready for inspection.
DIY With Training
This option is provided to assist business owners / project managers who feel capable of doing some of the heavy lifting and yet would prefer to retain the watchful eye of a trained consultant.