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How to apply ISO 62304 standard in a medical software dev't proj? (com) A

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How to apply ISO 62304 standard in a medical software development project?


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This course will give an introduction how to develop medical software under the requirements of the ISO 62304 and how to apply these in a medical software development project and how a smart application during the medical software development and in the post market process is possible. Further the risk management of medical software development. In the European Union is the application of the ISO 62304 for medical software mandatory and part of the essential requirements of the medical device regulation. In the technical documentation is required to approve the development process and the life cycle of medical software according ISO 62304.


Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

Learning Objectives:

  • What is the scope of the ISO 62304?

  • What are the requirements of ISO 62304 in medical software development processes and the medical software life cycle?

  • Which companies must apply ISO 62304?

  • How to implement ISO 62304 in a smart way into a medical software development project and in a quality management system according ISO 13485?

  • How to use the ISO 62304 in the Post Market Process according ISO 13485 and the EU MDR?

  • What are the expectations of European Notified Bodies?


Who will Benefit:

  • CEO’s

  • Regulatory Affairs

  • Quality Managers

  • Quality Assurance

  • IT/Software

  • Project Management


AGENDA

Day 01(8:30 AM - 4:30 PM)

8:30-8:59 AM Registration. Meet & Greet.
9:00 -11:00 AM Introduction into ISO 62304 (Overview about this standard, structure, scope)
11:00- 12:00 PM Scope, Normative References, General Requirements
12:00-1:00 PM Lunch
1:00-2:30 PM Software Development Process
2:30 – 3:00 PM Refreshments Break.
3:00-4:30 PM Software Maintenance Process


Day 02(8:30 AM - 4:30 PM)

8:30-8:59 AM Registration. Meet & Greet.
9:00 -11:00 AM Software Risk Management Process
11:00- 12:00 AM Software Configuration Management Process
12:00-1:00 PM Lunch
1:00-2:30 PM Software Problem Resolution Process
2:30 – 3:00 PM The Annexes of the ISO 62304
3:00-4:30 PM Answers & Questions


SPEAKER

Frank Stein

Prof. Dr. h.c. Frank Stein
Senior Medical Device Expert, Nemius Consulting GmbH

Dr. h.c. Frank Stein, medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac surgery and cardiology, industrial experience in ophthalmology, neurology, traumatology and dental implants, active implants, active devices, international project and regulatory consulting experience in Europe, North-America, Asia, Australia, Arabic Countries, Latin-America.


Please contact the event manager Marilyn (marilyn.b.turner@nyeventslist.com ) below for:
- Multiple participant discounts
- Price quotations or visa invitation letters
- Payment by alternate channels (PayPal, check, Western Union, wire transfers etc)
- Event sponsorships

NO REFUNDS ALLOWED ON REGISTRATIONS
Service fees included in this listing.
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