Medical device design is linked inextricably with risk management. Risk reduction measures become design inputs. Implementation verification, a risk management activity, can work as design verification too.
Governing it all is an alphabet-soup of Quality Management Systems (QMS) provisions including ISO 13485:2003, EN ISO 13485:2012, ISO 13485:2016, and EN ISO 13485:2016, as well as risk management requirements in the common Risk Management Systems (RMS): ISO 14971:2007 and EN ISO 14971:2012.
Register now for a study-up session with a leading authority on in quality, operations, and program management in medical device design and manufacture.
Dan O’Leary of Ombu Enterprises has a long track record training operations management professionals via a unique systems approach perfected over 30 years of training. In 90 fast-paced minutes, he’ll cover a lot of ground:
Overview: Design control from the risk management perspective
Overview: Risk management from the design control perspective
When, where and how the two system interact
Recognizing when requirements of the one system support/complement requirements of the other
Using product safety standards to improve design control and risk management efficiency
And much more!
Bonus! A chart showing relationships between the clauses of EN ISO 13485:2012 and EN ISO 14971:2012.
Better design and smoother operations benefit everyone — your employer, your customers, maybe your paycheck too. It’s well worth 90 minutes out of your week to sharpen skills and increase professional standing. Register now.