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Medical Device Technical File requirements: what you need to know

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

6 min read

ISO 9001 vs ISO 13485. What’s the difference?

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

4 min read

Implementing Medical Device Design Controls for ISO 13485 and FDA 21 CFR 820

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

5 min read

QMS documentation requirements in ISO 13485

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

4 min read

Will ISO certification give you a competitive edge?

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

5 min read

ISO 9001:2015 – How to apply Risk-based Thinking to Quality Processes [Part X]

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

5 min read

ISO 9001:2015 – How to apply Risk-based Thinking to Quality Processes [Part IX]

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

10 min read

ISO 9001:2015 - How to apply Risk-based Thinking to Quality Processes [Part VIII]

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

9 min read

ISO 9001:2015 - How to apply Risk-based Thinking to Quality Processes [Part VII]

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

9 min read

ISO 9001:2015 - How to apply Risk-based Thinking to Quality Processes [Part VI]

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

9 min read

ISO 9001:2015 - How to apply Risk-based Thinking to Quality Processes [Part V]

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

5 min read

ISO 9001:2015 - How to apply Risk-based Thinking to Quality Processes [Part IV]

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

10 min read

ISO 9001:2015 - How to apply Risk-based Thinking to Quality Processes [Part III]

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

5 min read

ISO 9001:2015 - How to apply Risk-based Thinking to Quality Processes [Part II]

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

7 min read

ISO 9001:2015 - How to apply Risk-based Thinking to Quality Processes [Part I]

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

5 min read

ISO 9001:2015 - The likely impact (Part II)

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

8 min read