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.
£75.00

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.
£185.00

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.
£350.00

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.
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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.
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Identifying and documenting key processes

Setting and delivering against meaningful objectives
£75.00

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.
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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.
Z

Risk Assessment of Medical Devices

Explaining the relationship with ISO 14971 and covering simplified methods of meeting both standards requirements.
Z

Identifying and documenting key processes

Setting and delivering against meaningful objectives
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Contents of a technical file

Maintaining the correct records
£185.00

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.
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Detailed explanation of the requirements of ISO 13485, 2016

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Identifying and documenting key processes

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Risk Assessment of Medical Devices

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Implementing and Certifying an Effective Management System

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Contents of a Technical File

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Setting targets for ongoing system improvement

£350.00

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.
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