Becoming familiar with IEC/ISO 62304 Software Life Cycle Processes for Medical Devices

by Chad Kymal,Michael B. Checketts,Antony John,Michael Edvardsson published on March 18, 2021

IEC/ISO 62304 is an international standard regarding Software Life Cycle Processes for Medical Devices. It is not as well-known as other medical device standards, but is now undergoing a significant revision. Software standards are taking on a more significant role these days. This is due to the number of devices that require software in order to operate correctly. Much like the medical device itself, software has a life cycle of its own, and in many cases, will be considered a stand-alone device (referred to as Software as a Medical Device, or SaMD). Watch the webinar recording as we discuss on the highlights and significant changes in this standard which will impact your Medical Device Software development.

Speaker

Chad Kymal

Chad Kymal is the CTO and Founder of Omnex Inc. He is the author of seven books and more than 100 papers including several on integrated management systems. Chad is currently on the writing committees for several standards including TC 22/ SC 32/WG 8 for ISO 26262 (Functional Safety), ISO/TC 176 for ISO 9001:2015 (Quality Management), ISO/TC 207 for ISO 14001:2015 (Environmental Management), and PC283 for ISO 45001 (Health and Safety Management Systems). He founded and was the CEO of an Automotive registrar for over 10 years and is familiar with conducting audits, being witnessed for audits, and also evaluating auditors and assessors. He authored and teaches a course for 3rd Party Auditors for Automotive Registrars on behalf of International Automotive Certification Bodies Association (IACBA). This course explains how 3rd Party Auditors audit IATF 16949 in an environment that includes ASPICE, Functional Safety and Product Cybersecurity. He is currently rolling out the course to global 3rd Party Auditors for IATF 16949. Chad has spent over 20 years in system, hardware and software development in various capacities. He assesses and works in automotive system, hardware and software for Agile, ASPICE, and Functional Safety ISO 26262. Chad is also currently an intacsTM certified Principal Assessor for Automotive SPICE.

Chad Kymal

Chad Kymal is the CTO and Founder of Omnex Inc. He is the author of seven books and more than 100 papers including several on integrated management systems. Chad is currently on the writing committees for several standards including TC 22/ SC 32/WG 8 for ISO 26262 (Functional Safety), ISO/TC 176 for ISO 9001:2015 (Quality Management), ISO/TC 207 for ISO 14001:2015 (Environmental Management), and PC283 for ISO 45001 (Health and Safety Management Systems). He founded and was the CEO of an Automotive registrar for over 10 years and is familiar with conducting audits, being witnessed for audits, and also evaluating auditors and assessors. He authored and teaches a course for 3rd Party Auditors for Automotive Registrars on behalf of International Automotive Certification Bodies Association (IACBA). This course explains how 3rd Party Auditors audit IATF 16949 in an environment that includes ASPICE, Functional Safety and Product Cybersecurity. He is currently rolling out the course to global 3rd Party Auditors for IATF 16949. Chad has spent over 20 years in system, hardware and software development in various capacities. He assesses and works in automotive system, hardware and software for Agile, ASPICE, and Functional Safety ISO 26262. Chad is also currently an intacsTM certified Principal Assessor for Automotive SPICE.

Chad Kymal

Chad Kymal is the CTO and Founder of Omnex Inc. He is the author of seven books and more than 100 papers including several on integrated management systems. Chad is currently on the writing committees for several standards including TC 22/ SC 32/WG 8 for ISO 26262 (Functional Safety), ISO/TC 176 for ISO 9001:2015 (Quality Management), ISO/TC 207 for ISO 14001:2015 (Environmental Management), and PC283 for ISO 45001 (Health and Safety Management Systems). He founded and was the CEO of an Automotive registrar for over 10 years and is familiar with conducting audits, being witnessed for audits, and also evaluating auditors and assessors. He authored and teaches a course for 3rd Party Auditors for Automotive Registrars on behalf of International Automotive Certification Bodies Association (IACBA). This course explains how 3rd Party Auditors audit IATF 16949 in an environment that includes ASPICE, Functional Safety and Product Cybersecurity. He is currently rolling out the course to global 3rd Party Auditors for IATF 16949. Chad has spent over 20 years in system, hardware and software development in various capacities. He assesses and works in automotive system, hardware and software for Agile, ASPICE, and Functional Safety ISO 26262. Chad is also currently an intacsTM certified Principal Assessor for Automotive SPICE.

Chad Kymal

Chad Kymal is the CTO and Founder of Omnex Inc. He is the author of seven books and more than 100 papers including several on integrated management systems. Chad is currently on the writing committees for several standards including TC 22/ SC 32/WG 8 for ISO 26262 (Functional Safety), ISO/TC 176 for ISO 9001:2015 (Quality Management), ISO/TC 207 for ISO 14001:2015 (Environmental Management), and PC283 for ISO 45001 (Health and Safety Management Systems). He founded and was the CEO of an Automotive registrar for over 10 years and is familiar with conducting audits, being witnessed for audits, and also evaluating auditors and assessors. He authored and teaches a course for 3rd Party Auditors for Automotive Registrars on behalf of International Automotive Certification Bodies Association (IACBA). This course explains how 3rd Party Auditors audit IATF 16949 in an environment that includes ASPICE, Functional Safety and Product Cybersecurity. He is currently rolling out the course to global 3rd Party Auditors for IATF 16949. Chad has spent over 20 years in system, hardware and software development in various capacities. He assesses and works in automotive system, hardware and software for Agile, ASPICE, and Functional Safety ISO 26262. Chad is also currently an intacsTM certified Principal Assessor for Automotive SPICE.

Chad Kymal

Chad Kymal is the CTO and Founder of Omnex Inc. He is the author of seven books and more than 100 papers including several on integrated management systems. Chad is currently on the writing committees for several standards including TC 22/ SC 32/WG 8 for ISO 26262 (Functional Safety), ISO/TC 176 for ISO 9001:2015 (Quality Management), ISO/TC 207 for ISO 14001:2015 (Environmental Management), and PC283 for ISO 45001 (Health and Safety Management Systems). He founded and was the CEO of an Automotive registrar for over 10 years and is familiar with conducting audits, being witnessed for audits, and also evaluating auditors and assessors. He authored and teaches a course for 3rd Party Auditors for Automotive Registrars on behalf of International Automotive Certification Bodies Association (IACBA). This course explains how 3rd Party Auditors audit IATF 16949 in an environment that includes ASPICE, Functional Safety and Product Cybersecurity. He is currently rolling out the course to global 3rd Party Auditors for IATF 16949. Chad has spent over 20 years in system, hardware and software development in various capacities. He assesses and works in automotive system, hardware and software for Agile, ASPICE, and Functional Safety ISO 26262. Chad is also currently an intacsTM certified Principal Assessor for Automotive SPICE.

Chad Kymal

Chad Kymal is the CTO and Founder of Omnex Inc. He is the author of seven books and more than 100 papers including several on integrated management systems. Chad is currently on the writing committees for several standards including TC 22/ SC 32/WG 8 for ISO 26262 (Functional Safety), ISO/TC 176 for ISO 9001:2015 (Quality Management), ISO/TC 207 for ISO 14001:2015 (Environmental Management), and PC283 for ISO 45001 (Health and Safety Management Systems). He founded and was the CEO of an Automotive registrar for over 10 years and is familiar with conducting audits, being witnessed for audits, and also evaluating auditors and assessors. He authored and teaches a course for 3rd Party Auditors for Automotive Registrars on behalf of International Automotive Certification Bodies Association (IACBA). This course explains how 3rd Party Auditors audit IATF 16949 in an environment that includes ASPICE, Functional Safety and Product Cybersecurity. He is currently rolling out the course to global 3rd Party Auditors for IATF 16949. Chad has spent over 20 years in system, hardware and software development in various capacities. He assesses and works in automotive system, hardware and software for Agile, ASPICE, and Functional Safety ISO 26262. Chad is also currently an intacsTM certified Principal Assessor for Automotive SPICE.

Antony John

Antony John is the Vice President of Omnex Systems. He has 19 years of experience transforming technology businesses across global markets and different customer industry segments, for profitable growth. Antony also possesses strong experience working in the Information Technology, Automotive, Aerospace, Oil & Natural Gas, and Insurance industries. He currently leads the Product Development of EwQIMS, a revolutionary software solution for managing Enterprise Quality for APQP, Integrated Management Systems / QHSE, and Supplier Quality used by Fortune 500 companies, OEMs, top automotive manufacturers, and large semi-conductor organizations across the globe.

Antony John

Antony John is the Vice President of Omnex Systems. He has 19 years of experience transforming technology businesses across global markets and different customer industry segments, for profitable growth. Antony also possesses strong experience working in the Information Technology, Automotive, Aerospace, Oil & Natural Gas, and Insurance industries. He currently leads the Product Development of EwQIMS, a revolutionary software solution for managing Enterprise Quality for APQP, Integrated Management Systems / QHSE, and Supplier Quality used by Fortune 500 companies, OEMs, top automotive manufacturers, and large semi-conductor organizations across the globe.

Antony John

Antony John is the Vice President of Omnex Systems. He has 19 years of experience transforming technology businesses across global markets and different customer industry segments, for profitable growth. Antony also possesses strong experience working in the Information Technology, Automotive, Aerospace, Oil & Natural Gas, and Insurance industries. He currently leads the Product Development of EwQIMS, a revolutionary software solution for managing Enterprise Quality for APQP, Integrated Management Systems / QHSE, and Supplier Quality used by Fortune 500 companies, OEMs, top automotive manufacturers, and large semi-conductor organizations across the globe.

Antony John

Antony John is the Vice President of Omnex Systems. He has 19 years of experience transforming technology businesses across global markets and different customer industry segments, for profitable growth. Antony also possesses strong experience working in the Information Technology, Automotive, Aerospace, Oil & Natural Gas, and Insurance industries. He currently leads the Product Development of EwQIMS, a revolutionary software solution for managing Enterprise Quality for APQP, Integrated Management Systems / QHSE, and Supplier Quality used by Fortune 500 companies, OEMs, top automotive manufacturers, and large semi-conductor organizations across the globe.

Antony John

Antony John is the Vice President of Omnex Systems. He has 19 years of experience transforming technology businesses across global markets and different customer industry segments, for profitable growth. Antony also possesses strong experience working in the Information Technology, Automotive, Aerospace, Oil & Natural Gas, and Insurance industries. He currently leads the Product Development of EwQIMS, a revolutionary software solution for managing Enterprise Quality for APQP, Integrated Management Systems / QHSE, and Supplier Quality used by Fortune 500 companies, OEMs, top automotive manufacturers, and large semi-conductor organizations across the globe.

Antony John

Antony John is the Vice President of Omnex Systems. He has 19 years of experience transforming technology businesses across global markets and different customer industry segments, for profitable growth. Antony also possesses strong experience working in the Information Technology, Automotive, Aerospace, Oil & Natural Gas, and Insurance industries. He currently leads the Product Development of EwQIMS, a revolutionary software solution for managing Enterprise Quality for APQP, Integrated Management Systems / QHSE, and Supplier Quality used by Fortune 500 companies, OEMs, top automotive manufacturers, and large semi-conductor organizations across the globe.

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