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
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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
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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.

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Local Attractions of Zurich, Switzerland

Kunsthaus Zurich

Kunsthaus Zurich

The Kunsthaus is Zurich's most important art museum and one of the most famous in Europe. Although the collection of the Kunsthaus Zürich ranges from Ancient times to the Victorian Era, the Swiss art museum is most noted for its modern and contemporary works from the 19th and 20th centuries. Top exhibits include the Giacometti wing and Rodin's Gate of Hell.

Bahnhofstrasse

Bahnhofstrasse

Widely known as the principal boulevard in Zürich, the Bahnhofstrasse is Zurich's most famous shopping street. Lined with some of the city's most elegant boutiques and top department stores, the Bahnhofstrasse offers a delightful place for a day of shopping amongst some of the world's greatest luxury brands and jewelry stores.

Zurich Zoo

Zurich Zoo

Elephants, rhinos, tigers, penguins and 20 species of monkeys are just some of the more than 360 animal species that can be admired at the Zurich Zoo. In the Masoala Rainforest Hall visitors can experience a piece of Madagascar first hand. A must-see for young and old.

Limmat River

Limmat River

Switzerland's Limmat River is actually part of the Linth river, which continues from Lake Zurich. Zurich is the most famous city located along the Limmat Valley and the Limmat River provides a charming and beautiful waterway to explore the sights of Zurich by boat.

Fraumunster Church

Fraumunster Church

The Fraumünster Church overlooks one of Zurich's oldest squares and markets, the Münsterhof. Tracing its founding back to 853, when it was a Benedictine abbey, the church is home to five famous stained-glass windows by renowned artist Marc Chagall.

Zurich Old Town

Zurich Old Town

Zurich Old Town (Altstadt ) is a cultural, social and historical melting pot. The highest concentration of clubs in Switzerland, one of the most famous shopping miles, and a plethora of cultural offerings

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