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10 Jul 2019

[Video] New Learner Advisory for our e-Training

certified training company, internal auditor, ISO 19011, iso 9001, iso 14001, iso 17025, iso 45001, e-learning, iso 13485, iso 27001, iso 14971

Helps the New Learner get to know how our Learning Management System (LMS) works and delivers our Courses and to avoid the 'rookie' e-training errors.
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04 Jul 2019

[Video] When ISO Auditor Training is hard to find ...

certified training company, internal auditor, ISO 19011, iso 9001, iso 14001, iso 17025, iso 45001, e-learning, iso 13485, iso 27001, iso 14971

If you’re responsible for Learning & Development, you will frequently struggle to get the training you need when and where you need it. And if you want ISO Auditor Training now, forget it.  Well, not quite. Our online ISO Auditor Training may be your solution.  Have a look ...
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18 Apr 2019

EU MDR to result in withdrawal of devices from the market

MDMS, risk management, iso 13485, iso 14971

Without an immediate action, tens of thousands of medical devices will be withdrawn from the EU regulatory area next May. MedTech Europe, a European trade association for the medical technology industry including diagnostics, medical devices and digital health, have issued an open letter (dated 15th April 2019) to the European Commission on the implementation and readiness status of the new ...
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05 Apr 2019

Choosing the right Risk Assessment Tool

MDMS, risk management, iso 13485, iso 14971

Using FMEA alone is the lazy choice ISO 14971, Medical devices - Application of risk management to medical devices, and ISO 31010, Risk management -
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14 Feb 2019

ISO 13485 Risk Management and Risk-based Thinking - both required

MDMS, risk management, iso 13485, iso 14971

There are two distinct and different requirements in ISO 13485:2016 for the management of risk.  One relates to the management of the processes that go to make up the ISO 13485 Quality Management system.  And the other relates to patient/end user safety, that is, safety in manufacturing.  The difference between the two is often missed, especially by component manufacturers, as is the issue of ...
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