Michael Engler Email & Phone Number

Essen, Nrw, De

Essen

I believe products, software, and services reach a whole new quality if we use human-centered design. Great products feel magic to customers, but developing such products or services is no magic, but simply following best practices in human-centered design. I can help you with that. By the way, this ensures you get the most out of your development effort! And then it saves lives avoiding use errors (errors made by users when working with a product or service). I believe that safe and secure products are required in hospitals. I am glad that I can help on the software side of things.My specialties: Making usability engineering and software engineering happen for medical devices.(IEC 62304/A1:2015, IEC 62366-1:2015, IEC/TR 62366-2:2016, ISO 14971, ISO 13485; FDA: Chapter 21 Part 820, Chapter 21 Part 11, and relevant guidance documents for human factors and software). https://www.benkana-interfaces.com/?page_id=308

Germany

Medical Device Knowledge Unit is an association that support the digitzation of medical device and IVD technical documentation by creating a unifed data model that aims to be able to exchange information electronically e.g. also with notified bodies.

Linz

Teaching usability engineering and requirements engineering for master students of medical device design.

Consultant and trainer for usability engineering, requirements engineering, agile software development, and regulatory affaires for medical device design.

Working as a software process improvement consultant in the Automotive industry using SPICE, ISO 15504, Automotive SPICE, especially knowledgable in requirements engineering, usability engineering, project management, SCRUM, agile methodologies

Worked on NM2 (http://www.ist-nm2.org, EU-funded) collaborative project exploring the chances of dynamic content production and interactive tv.Project management for a research topic on recommender systems for IPTV focusing on user interaction and trials.