Navigating the Regulatory Landscape for Innovative Biomedical Applications

<You can view the webinar recording here>

NXTGEN Hightech Biomedical and High Tech NL invite you to join us for an insightful webinar on September 4, 2024, from 16:00 to 17:00 CET.

This engaging and practical webinar will feature hands-on advice drawn from the extensive experience of QServe, a leading consultancy in regulatory affairs. Attendees will gain valuable insights into:

• The importance of early regulatory involvement

• Essential milestones necessary for preparing the launch of your biomedical innovations

Who Should Attend?

This webinar is designed for professionals in the fields of Biomedical Engineering, Applications, and Life Sciences who are keen to navigate the complex regulatory landscape and successfully bring their innovations to market.

Register on time because there are limited spots available for this webinar.

Programme:

• Welcome by Edwin Roovers, High Tech NL Life Science

• How to bring your idea to the market

  • Which is the first country I want to market my device?

  • Classification > Do I have a device?

  • High level overview IVDR, MDR, FDA

  • Manufacturing & responsibilities

  • Choosing suppliers, subcontractors and OEM's

• Case study lab-on-chip

  • Early phases what's important

  • What is worth investigating

  • Common mistakes

  • Time vs cost

  • Exit strategy

• Q&A

  • If you already have questions upfront, please send them to lifesciences@hightechnl.nl , and we will try to answer them during the webinar or at a later stage.

Speakers:

• Sue Spencer, Head of IVD, EU Regulatory & Quality Expert, Principal Consultant

  Sue leads Qserve’s IVD service, is EU Regulatory and Quality Expert including CDx and Lead Auditor. She has over 30 years’ of experience in the Medical Device and IVD industries including extensive notified body experience.

• Robert Paassen, MSc, Regulatory Affairs & Quality Assurance, EU MDR Lead, Consultant

  At Qserve, Robert has worked for several customers as Quality and Regulatory Officer, supporting them with and/or creating Clinical Evaluations, Quality Management System remediation projects, CAPA management, risk management, postmarket surveillance plans, responding to Notified Bodies on any non-conformities found during audits, conducting and supporting audits, training on ISO13485, MDSAP and MDR.

Don’t miss this opportunity to enhance your understanding of regulatory requirements and accelerate your path to market success.

We look forward to your participation.