Medical Device Safety And Regulations Compliance Forum

Ensuring Safety and Competitiveness in the Medical Device Market Through Comprehensive Human Centricity, Innovation, Digitalisation, and Regulatory Compliance

2 — 3 June, 2022 Berlin

The event has already occured.

Key facts

Date: 2 — 3 June, 2022

Place: Berlin

Conference Overview

The world is working on bouncing back at a normal life after a destructive pandemic, and humanity’s collective awareness of the importance of the healthcare sector has consequently climbed up. Be it a simple nebulizer or an advanced robotic surgical system, each medical device needs to be produced with the highest level of attention and innovation in order to address the overarching needs of today’s medical world. Therefore, developing modern, technologically advanced, and low-risk medical devices is more important than it has ever been for the healthcare sector.

A single medical device can be life-changing for a patient when it is used correctly and as long as it operates successfully; yet achieving this comes with many challenges. It is vital for healthcare institutions to ensure the effectiveness and safety of operating medical devices to avoid pitfalls. In order to achieve this, building a strong and meaningful network between medical leaders around the world is necessary to secure a flow of knowledge and experiences that serve the well-being of human life.

To serve this aim, the Medical Device Safety and Regulation Compliance Forum by GlobalBSG creates a collaborative platform for executives involved in the regulation, design, product safety, development, innovation, technology, monitoring, and quality aspects of medical devices. Industry professionals will exchange field knowledge and useful practices in producing high-quality medical devices and keeping the safety level at the highest level through advanced risk management strategies.

Key topics

  • Awareness-raising on the impact of compliance on the medical device industry for market enlargement and competitiveness aspects
  • Artificial intelligence and machine learning-based software as a medical device safety transformation action
  • Applying human factors and usability engineering to medical devices
  • Meeting proper regulatory requirements and highest quality standards in post-pandemic health sector & keeping up with today’s trends
  • Sharing best practices and guidelines for monitoring and evaluating the safety of medical devices through post-market surveillance strategy
  • Collaborative management of performance, safety, economics, risks and regulatory requirements as the core for device design
  • Ensuring a successful risk management plan and product lifecycle while leveraging innovation
  • Accelerating into the medical market and noticing the opportunities and challenges & efficient and frequent prototyping in the development cycle
  • Developing an effective change management system & Improving patient safety and security through improved resilience and cybersecurity practices

Who should attend

Chief Executives, VPs, Directors, Managers, Department Heads, Leaders of

  • Quality Management
  • Clinical Quality Management
  • Quality Assurance
  • Regulatory Affairs
  • Medical Affairs
  • Medical Device
  • Risk Assessment
  • Compliance / Ethics
  • Monitoring
  • Research and Development
  • Project Management
  • Pharmacovigilance
  • Safety
  • Data Management
  • Real-World Evidence
  • Adverse-Events / Case Management Service Providers
  • Audit
  • MDR & IVDR

Target audience

  • Medical Device Manufacturers
  • Medical Device Vendors
  • Healthcare / Pharmacovigilance Companies
  • Biotech Companies
  • Biomedical Companies
  • Technology, Data, Analytics, and Digital Infrastructure Providers
  • Hospitals

Event Speakers

James Whitehead

Director of Patient Safety – Medical Devices

AstraZeneca

Rajit Kamal

Worldwide President, Sports Medicine

Johnson & Johnson

Andreas Stange

Vice President of MHS Global

TÜV SÜD

Dr. Peter Drechsler

Director of Quality Management & Regulatory Affairs

Caresyntax

Bijan Elahi

Advisor, educator, author - Product Safety Risk Management

Medtronic

Mario Lois

Global Head & Senior Director of Artificial Intelligence

GE Health

Corine Broekhuizen

Director of Quality & Regulatory Affairs

ICU Medical

Rea Castro

Medical Director - IVDR Lead

Abbott

Pat Baird

Regulatory Head of Global Software Standards

Philips

Leon Doorn

Head of Regulatory Compliance

Aidence

Marta Carnielli

IVD Technical Director

TÜV SÜD

Richard Houlihan

CEO

EirMed Ltd

Christopher Frenz

Information Security Officer

Mount Sinai South Nassau

Raj Takhar

Subject Matter Expert - Materials Management and Chemical Reporting (Europe)

Assent

Coenraad Davidsdochter

Senior Consultant & AI Specialist

Qserve Group

Hakan Inan

Founder and Managing Director

Requalite GmbH

Ella Helgeman

Regulatory and Quality Manager

Intertek

Bassil Akra

CEO

Akra Team GmbH

Erman Melikyan

Principal Clinician

Intertek

Randy Horton

VP of Solutions and Partnerships

Orthogonal

Ajay Panwar

Sr. Engineering Manager, New Product Introduction Quality

Medtronic

Kushal Kadakia

Special Projects Manager to the CEO

Cleveland Clinic London

Event location

The Conference will be taking place at Steigenberger Airport Hotel Berlin

Willy-Brandt-Platz 3 | 12529 Schönefeld, Germany

Hotel website

Business Development Partner

Silver Sponsor

Companies attending the conference

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