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What is the medical device technical file? What should it contain and how should it be structured? And is it e...

ISO 9001 is the internationally recognised standard for quality management used in many sectors from construct...

30 years ago the FDA introduced robust new requirements for medical device design control following a string o...

  How should you structure your documentation to meet the requirements of ISO 13485?

Documenting your SOP (standard operating procedures) can be a drag. It can feel unnecessary for a relatively s...

The expense and effort of achieving ISO certification is sometimes regarded as excessive and onerous by SMEs -...

There are twelve posts in this series. To read Part IX, please click here. In this and the following two posts...

How to apply Risk-based Thinking to Quality Processes - a Summary There are twelve posts in this series. To re...

RISK MANAGEMENT METHODOLOGY FOR QUALITY MANAGEMENT Steps 4-6 in the method There are twelve posts in this seri...

There are twelve posts in this series. To read Part VI, please click here.  Steps 1-3 in the method If you hav...

  There are twelve posts in this series. To read Part V, please click here. Risk based thinking is the new 'pr...

SO 31000 Risk management techniques - continued Attributes of a selection of risk assessment tools   There are...

ISO 31000 Risk management techniques - continued There are twelve posts in this series. To read Part III, plea...

ISO 31000 Risk management techniques Attributes of a selection of risk assessment tools If you haven't yet rea...

ISO 31000 Risk management techniques: A selection of risk assessment tools you might like to consider Part 1 i...

Why taking a risk-based approach is a requirement of ISO 9001 Risk-based thinking is a sore point among many Q...

There are twelve posts in this series. To read Part I, please click here. Risk-based thinking and the resultin...