Without doubt, the new medical device regulations add an increased focus on risk management. Most manufacturers base their risk management processes on the ISO/EN ISO 14971 standard, but to stay compliant they will need to update their risk management processes.
Focus on risk management – new edition of the ISO 14971 risk management standard
The ISO 14971:2019 version of the standard, which has been updated to be better aligned with new regulations, arrived in December 2019, together with the corresponding European version EN ISO 14971:2019. The Swedish version SS-EN ISO 14971:2020 followed in January 2020.
The risk management process itself has not changed, but the new edition brings clarifications and adds details to help implement an efficient and compliant risk management system. The new edition of the associated guidance document, ISO 24971, is due to be released soon, and this document includes guidelines on how to implement risk management according to ISO 14971.
Make the most of your internal audits
The fact that regular internal audits are mandatory for all medical device companies is intimidating to many. But instead of viewing these audits as a necessary evil, think of them as a tool for developing your company’s processes and for achieving compliance with ISO 13485 and applicable regulations.
To help you do this, we offer a 2-day course – Internal audits based on ISO 13485 – for MedTech organisations. In this course, you will learn how to prepare for internal audits to make them efficient and to adapt them to your own company’s operations so that they become more useful to you. The course also includes practical exercises, going through each step of an internal audit, so that you know what they are.
QAdvis Academy provides both open courses and seminars and customer site specific training events.
Read more in our calendar.
Meet us in person
Emma Axelsson gave a presentation about the MDR at our January breakfast seminar. Do you have questions about the MDR? Talk to Emma at Regulatory Summit 2020, which has an emphasis on the MDR this year.
Regulatory Summit 2020 is hosted by Swedish Medtech and it takes place at the World Trade Center in Stockholm on 20 February. QAdvis will participate as one of the exhibitors. We look forward to meeting you there!
QAdvis Academy highlights
Medical device software process design based on IEC 62304
2-day open course 27–28 February, Malmö
This course gives an understanding of how to develop high quality software in a regulated environment and achieve regulatory compliance. Read more about this open course and register here.
Internal audits based on ISO 13485 – for medtech organisations
2-day open course 12–13 March, Malmö
This course provides an introduction to internal auditing for medtech professionals, including an overview of the requirements of the current standard. Exercises and examples are all related to ISO 13485.
Read more about this open course and registerhere.