Regulatory and quality requirements for the design and development of Medical Device Software In-house Training

Twenty-five years ago, software did not feature significantly in medical device legislation. Thirteen years ago it was added as a serious afterthought. As Europe moves to the new Medical Device Regulations, software is recognised throughout the General Safety and Performance Requirements. It has its own rules in classification, whether it is software as a medical device or software as the driver of a medical device. Software has come to the attention of the regulators as a serious source of risk and benefit. This sequence of seminars aims to help those involved in medical device software to understand intricacies of the regulatory burden and how early adoption of the solutions minimises both the costs and time to market.

EVENT INTRODUCTION

Twenty-five years ago, software did not feature significantly in medical device legislation. Thirteen years ago it was added as a serious afterthought. As Europe moves to the new Medical Device Regulations, software is recognised throughout the General Safety and Performance Requirements. It has its own rules in classification, whether it is software as a medical device or software as the driver of a medical device. Software has come to the attention of the regulators as a serious source of risk and benefit. This sequence of seminars aims to help those involved in medical device software to understand intricacies of the regulatory burden and how early adoption of the solutions minimises both the costs and time to market.

Who should attend?

• Writing software for Medical Devices or writing software as a Medical Device
• Implementing the EU Medical Device Regulation in their organisation
• Writing technical files or quality systems for the EU Medical Device Regulation
• Quality Engineers or Regulatory Affairs professionals

REQUEST A TAILOR-MADE OFFER
REQUEST A TAILOR-MADE OFFER
Regulatory and quality requirements for the design and development of Medical Device Software In-house Training
Name
Corporate email
Corporate phone
I give my consent to receive more information about GLC Europe's events, news, and offers
Privacy Policy

Past Clients

Testimonials

The level of professionalism of the trainer. Fine-tuned program without wasting time

Managing Director – European pharma company

Testimonials

Clear and interesting way of presenting issues, good examples and very knowledgeable trainer.

HR Director - Multinational company based in Europe

Testimonials

Excellent trainer, super skilled, funny and extremely dynamic

M&A Professional

Testimonials

This training was interesting and I would love to attend more trainings like this.

HR Professional

Testimonials

All lectures of the trainer was exactly what I was looking for and it was directly related to my experties and area that I am working. On top of that he prepared all lectures in a very practical way and also took his time to asnwers to the questions and he made sure that we got the asnwer. The organization of this class was also very good.

Pharmaceutical professional

Testimonials

Comprehensive overview with very knowledgeable and experienced trainers. The break-out sessions were great as they made the course more interactive and allowed us to apply the concepts in practice.

Banking professional from Europe

About GLC EUROPE

Global Leading Conferences is specialized in designing, creating and executing impactful, and pragmatic Conferences, Masterclasses and in-house training.

We take pride in empowering thousands of professionals around the world to learn, network, make connections, and do business with thought leaders and visionaries across multiple industries.

GLC actively collaborates with professionals in major sectors, such as Finance, Pharmaceutical, Human Resources, Health & Safety and Energy to understand the challenges and issues that each industry endures, to be able to construct exclusive and top-tier learning and networking platforms.

Specialized in planning, designing, and organizing interactive, impactful, and pragmatic B2B events, GLC actively collaborates with professionals in major sectors, such as Finance, Pharmaceutical, Human Resources, Health & Safety, and Energy to understand the challenges and issues that each industry endures.

10
years

of constructing industry focused events where business meets intelligence

299
events

where we have been learning to provide a unique experience for our customers

3410
speakers

from top-notch industry establishments proven to make a difference

17761
clients

thereof 96% would attend a GLC event again and would recommend GLC

The MANAGEMENT

GHAZAL ZOHREHNEJAD

Managing Director / Co-founder

LÁSZLÓ ÁRVAI

Managing Director / Co-founder

KRISZTIÁN ÖTVÖS

Managing Director / Co-founder