Webinar:

Refurbishing Medical Devices: the Update Journey

Sponsored by: Critical Software

Focused on:

  • Medical Device Refurbishment
  • Regulation
  • User Experience
  • Certification
  • Medical Devices Software

Date: 25 May

19

Time: 2PM London/3PM CET

How to Succeed in Medical Device Refurbishment

Refurbishment is a well-established aspect of the global healthcare economy - and it's growing, with the market projected to reach € 17.6 billion by 2025. This includes repairing, reworking, updating and, when needed, replacing devices. Done right, it allows manufacturers to extend the device's lifetime while easing the certification process and assuring a fast return to the market. Done wrong, costs can spin out of control, certification failure becomes a real risk and time-to-market deadlines can be easily missed.

In this webinar, Critical Software will focus on medical devices updates and how to avoid some key issues including:

- Regulations relevant to the refurbishment process and the impact of medical device updates on certification
- How to use legacy code in a refurbishment project and the risks and limitations you should account for
- How to guarantee that updates on UxD won’t jeopardise patients’ safety and certification.

Join us and take your first step towards efficient medical device refurbishment.

Presented by

Jorge Almeida,

CTO (Critical Software)

Experienced safety critical embedded systems engineer, having worked in a variety of industries from defence and space to, more recently, railway.

Career spans fields including SW development, embedded systems development, electronic systems testing, RAMS and certification support projects, offering a strong insight into how safety critical systems should perform.

A deep knowledge of the field and a capability for problem-solving provide the perfect attributes for offering solutions to Critical Software’s customers with a high degree of confidence and quality.

Paolo Massari,

Medical Device Expert (FSQ Experts)

Experienced professional in the medical sector with a unique combination of technical expertise, clinical experience, product design, quality management and production support to lead the delivery and implementation of high miniaturised technical medical devices (Class III Medical Devices - neurostimulators) with the relative software and firmware.

Enthusiastic about medical technology, science and math, with a strong computer science background.

Luis Coelho,

Principal Engineer (Critical Software)

Currently a Principal Engineer at Critical Software, focusing on medical devices.

Previously managed different types of projects as a Project Manager, with teams with a variety of skills and competences. Responsible for project planning, scope and cost management, and risk analysis.

Created a new business unit focused on developing and installing AGVs (automated guided vehicles) in active space technologies. Gained experience in the development of hardware and software as a system engineer, then transitioned to Project Manager and finally to a business unit management position.

In the business unit management position, covered industries including automotive, food, intralogistics and pharmaceutical.

Ana Luísa Carvalhal,

UI/UX Designer (Critical Software)

Obtained a degree in Communication Design, specialising in Human-Computer Interaction. Worked for over 15 years as a UI/UX Designer in different business areas such as healthcare, smart homes and business management.

Currently working as a UI/UX Designer and Product Owner for several projects at Critical Software.

Key Learning Objectives

  • The opportunities and challenges arising from medical device updates.
  • How to use legacy code in a refurbishment project, and the risks and limitations you should account for.
  • The impact of regulations on the refurbishment process - and the effect of medical device updates on certification.
  • How updates can be the perfect opportunity for an interface facelift, and the challenges that may arise.

Audience

  • Engineering Director - Engineering Manager - Head of Engineering
  • Director of Software Development - Software Development Manager
  • Product Director - Product Manager - Head of Product development
  • Head of R&D - Director of R&D
  • Principal Software Engineer - Principal Software Developer - Senior Software Engineer - Senior Software Developer
  • Principal Systems Developer - Senior Systems Engineer
  • Program Manager - Program Director
  • Software team leader
  • Engineering Project Manager
  • Software V&V Manager - System Design Manager - Senior System Design Engineer
  • Verification & Validation Manager - Verification & Validation Director - Verification & Validation Team Leader
  • Safety Assurance Manager
  • Head of cyber-security - Director of cyber-security - Cyber-security Manager
  • Regulatory Affairs Director - Regulatory Affairs Manager
  • Head of Certification