Daily stories in the media confirm that there is no organization, no matter how big or small, nor what sector it works in, that isn't susceptible to cyber breaches -- with phishing attacks leading to ransom demands at an all-time high.  All information is valuable both to your own organization and to the interested parties who include your customers, your suppliers, governmental and regulatory ...

Currently, there are two versions of ISO 13485 or the Medical Device Management System (MDMS) standard: ISO 13485:2016 and EN ISO 13485:2016. What’s their significance, if any, for medical device manufacturers and for component manufacturers, logistic suppliers and other organizations servicing the sector? In this post, we will explore the situation and provide the answers.   Table of Contents ...

  Do you need formal Risk Management or not? One of the key changes in the 2015 revision of ISO 9001 was a requirement to establish a systematic approach to considering risk, rather than treating “prevention” as a separate component of a quality management system.

The requirement is for a product lifecycle approach. i.e. from initial concept to end-of-life disposal

There are 2 Courses available for the effective Risk Management of Medical Devices One of the primary reasons for the revision and extension of the ISO 14971 Standard in 2019 was to extend the application of risk management tools beyond the blanket application of FMEAs alone to the protection of patient and end-user safety.  Two examples of where other tools are far more appropriate would be ... ...

Is ISO 13485 Certification relevant to providers of products and services to the Medical Device Supply Chain? The answer: a definite yes. The auditing standard, ISO 19011, brings Supply Chain risks and other issues to the ISO Auditors’ attention. And the 2016 version of the ISO 13485 Standard was written with this in mind (see Section 1). Here are some of the key Medical Device Supply Chain ...

ISO 13485 Certification for those not making Medical Devices Where do I start if I want to get Certified to ISO 13485? This is a question frequently asked by those involved in the medical device supply chain (e.g. component manufacturers and logistics companies) who have no experience with medical device manufacture. With a steady, if slow, increase in medical device companies requiring ISO 13485 ...

Whether you are starting from ‘scratch’ or whether you already have an Environmental Management System, a Gap Analysis is essential to establish which are the issues and topics that your EMS Project Plan will need to address.