Every ISO standard has the system of requirements and each one of them is described in segments. In general requirements, it’s established what is meant by: QMS establishment The key point with QMS establishment is to be done in accordance with the requirements described in this exact standard. And by… 

Let’s say you have an idea of placing an innovative medical device on the market. That’s great, but you already know that going from idea to actual realization is not the whole picture, just the tip of the iceberg. Yes, there is a much larger part below… 

1. What is an ISO 13485? ISO 13485 is an international standard for establishing quality management in the medical device industry. It is an effective explanation to meet the comprehensive requirements for a QMS in the medical device industry. The other well-known QMS requirements to follow… 

Surprisingly, this is a real and topical question. At every MedDev or MedTech oriented exhibition this is the off-stage topic, actually more like the main grippe session. The 2016 ISO version requires a lot more emphasis on risk management and embedding risk management into the… 

Be careful what you use when building up your QMS system! The expanding Internet means more: more data, more collaboration, and more complex systems of interactions. You can find hundreds of both expensive and free templates for ISO 13485, offered by various consultants, companies and… 

Medical Devices – Quality Management System – Requirements for Regulatory Purposes The world’s most popular standard for medical device quality management has been revised for the first time since 2003: Medical Devices – Quality Management System – Requirements for Regulatory Purposes. The revised standard ISO 13485:2016 was published… 

What is a role and how does it connect to processes? The 2016 edition is much more complicated than the 2003 edition so here is a little help to make things a little more understandable. In ISO 13485:2016 there are many new terms, definitions, and… 

Differences and similarities between the ISO 13485:2003 and ISO 13485:2016 editions. ISO 13485:2003 only had a few defined terms with clear definitions. However, in the new edition of ISO 13485:2016, sixteen new terms are added with longer definitions. Let’s see what are the differences and… 

May 2016 was a dark period for medical small companies and startups, it was the day the ISO created a glass ceiling for Medical Startups. A glass ceiling! Yes, because ISO13485:2016 essentially puts a glass ceiling on medical start-ups with a daunting new array certification requirements that will…