Complimentary Seminar:
BSI x MTAA Meet the Experts: From MDR Excellence to European Market Access
In the evolving landscape of the EU Medical Device Regulation (MDR), technical knowledge is only the baseline. Compliance demands a strategic mastery of documentation, transforming complex data into a seamless, compliant narrative that stands up to the most rigorous regulatory scrutiny.
In collaboration with BSI and the Medical Technology Association of Australia (MTAA), this session brings together industry expertise and regulatory insight to deliver real-world guidance for medical device professionals.
We dive deep into the “how-to” of technical documentation. This event is your roadmap for navigating the critical intersection of clinical data and compliance, ensuring your submissions are structured for precision and compliance.
Join us BSI x MTAA Meet the Experts: From MDR Excellence to European Market Access, an intensive session meticulously designed to bridge the gap between regulatory theory and audit-ready execution.
In this session, BSI experts will share insights on:
- Clinical Evaluation
- Technical Documentation for MDR Excellence
Complemented by MTAA session on:
- From Compliance to Market: Navigating European Market Entry for Australian MedTech
Agenda
| Time | Activity |
| 14:00 - 14:30 | Registration |
| 14:30 - 14:45 | Welcome Address |
| 14:45 - 15:15 | Session 1 Clinical Evaluation |
| 15:15 - 15:45 | Session 2 Technical Documentation for MDR Excellence |
| 15:45 - 16:00 | MTAA Session From Compliance to Market: Navigating European Market Entry for Australian MedTech |
| 16:00 - 16:30 | Q&A Session |
| 16:30 - 17:00 | Afternoon Tea Session and Networking |
About the Speakers
Joanne Daniels - Senior Technical Specialist & Scheme Manager, BSI.
Joanne Daniels is a Senior Technical Specialist and Scheme Manager within BSI’s Medicinal & Biologics team. She conducts technical and clinical assessments for IVF/assisted reproduction devices and serves as a technical assessor for MDR Article 117 submissions, evaluating the device elements of drug–device combination products.
With a PhD in Molecular Genetics and industry experience in medical device development and regulatory strategy, Joanne brings strong scientific and technical expertise to the conformity assessment process. She is dedicated to supporting manufacturers in navigating the requirements of the EU MDR and ensuring that medical technologies demonstrate robust safety and performance.
Jeanie Manning - Technical Specialist & Scheme Manager, BSI.
Jeanie Manning is a Technical Specialist and Scheme Manager within BSI’s Medicinal and Biologics Team, bringing more than 15 years of experience across scientific research, product development, and global medical device regulation. With a PhD in Molecular Cell Biology and a career spanning roles in R&D, IVF media development, and clinical evaluation and post-market surveillance, Jeanie has worked across a diverse portfolio of Class I–III implantable medical devices, including specialised expertise in ART and IVF technologies.
In her role at BSI, Jeanie performs technical assessments including clinical evaluations and is also responsible for managing client certification schemes, ensuring they meet regulatory, accreditation, and internal quality requirements.
Teneille Murray - Innovation & Growth Lead, MedTech Compass, MTAA.
Teneille Murray is the Innovation & Growth Lead at MedTech Compass, MTAA's dedicated program supporting Australian medical technology companies to innovate, scale, and access global markets. With a passion for connecting Australian MedTech businesses to the right people, programs, and pathways, Teneille works closely with founders, commercial leaders, and industry stakeholders to accelerate growth at every stage, from early-stage innovation through to international market entry.
Teneille leads engagement across trade delegations, international showcases, and industry development initiatives, with a particular focus on helping Australian companies navigate the complexities of entering regulated markets including the European Union. Teneille brings a hands-on, commercially minded approach to innovation and growth, and is committed to strengthening Australia's position as a global MedTech hub.
How to Register?
Limited seats available. Registration is required and complimentary, with a maximum of two (2) participants per company.
Please RSVP by Monday, 11 May 2026 by clicking 'Register Here' to confirm your attendance. A confirmation email will be sent upon successful registration.
For any enquiries, please contact Arjun Joshi, Senior Business Development Manager, BSI ANZ or Seetal Erramilli, Business Development Manager, BSI ANZ.
Email: Arjun.Joshi@bsigroup.com / Seetal.Erramilli@bsigroup.com
