Medical Device compliance of your Technical Documentation – how to achieve successful submission to the authorities

There is an increasing focus on the effectiveness on the submission process for market access of medical devices in Europe and in US. Due to the new regulation in Europe and general increasing scrutiny of Technical Documentation from the companies there is an increasing backlog and delays of review seen with the authorities. This is a frustration to both the companies and the authorities.
The Authorities are reporting general observed issues that can increase the efficiency and thereby support the whole industry. This includes:
- Lack of a good overview and Executive Summary of the File.
- Complicated filed where information are not easily found (reference to a reference to a reference….).
- Data Inconsistency, etc.
At this workshop we will walk through the process of creating a good Technical File and staying compliant with the the regulation, by hearing real life experience from the experts.
Key components
- EU MDR and FDA
- Requirement of clinical data
- Article 61 compliance
- Typical audit findings of the Technical File
- PRRC role
- How to build TF prior to submission to NB
- Findings and real life experience
Programme
12.00-12.30 Registration & light lunch mingle at Sharience.
12.30-12:35 Welcome from Medicon Village and introduction to QMed.
12.35-13:20 ”Regulatory Requirements of Clinical Data under the Medical Device Regulation – Read-Along and Discuss Article 61 and Annex XIV”, by Mette Sørensen, Internal Clinician, TÜV SÜD Denmark Medical Health Services.
13:20-14:25 “Technical File and how to be successful in your application with the Notified Body communication.”, by Laura Schmitt, Principal Advisor Qmed Consulting A/S.
14:25-15:00 “Role of PRRC in ensuring that the technical file is well-prepared and comprehensive for successful submission and Notified Body approval – seen from the medical device manufacturer side”, by Ella Helgeman, MSc EE, MBA, Regulatory and Quality Director, Rehaler A/S.
15:00-15:15 Q&A.
15.15-15:45 Coffee mingle.
Speakers
- Mette Sørensen, Internal Clinician, TÜV SÜD Denmark Medical Health Services.
- Jens Johansen, Sr. Principal Advisor, Qmed Consulting A/S.
- Ella Helgeman, MSc EE, MBA, Regulatory and Quality Director, Rehaler A/S.
About Qmed
Qmed, a full-service Clinical Research Organization and Consultancy specializing in medical devices, plays a pivotal role in assisting developers and manufacturers in navigating the regulatory landscape and gaining market access in key markets. Our hallmark lies in crafting the requisite Technical Documentation and establishing the written procedures essential for supporting this process. Qmed extends leadership and support throughout the intricate journey of product approval, offering expertise in various domains, including:
- Regulatory Affairs and Strategic Planning – Including: Design Control and Manufacturing.
- Clinical Development and Strategy: including Clinical Evaluation Process and Documentation (CEP, CER, CDP, PMCF Plans, and Reports, SSCP and PSUR report).
- Quality Assurance (ISO13485).
- Market Access and Reimbursement.
Information
- When: to
- Where: Sharience, The Spark building, Medicon Village, Scheeletorget 1, Lund
- Organizer: Medicon Village in collaboration with Qmed Consulting
- Language: English
Registration
Please register no later than Tuesday 16 April 2024
Contact information
- Lottie Norrsén
- lottie.norrsen@mediconvillage.se
- https://