AKRA TEAM

Wir sind gerade live im Webinar ??????????????-?????????????????????? – ?????? ?????? ???????????????? ???? ?????????????????????? ?????? ???????????????????? ??????????? ?????? ?????????????????? ???? ???????????????????? ???????????????? ???????? mit Dr. Bassil Akra und Natasa Mitrovic MSc. ? Stehen Sie aktuell vor Herausforderungen hinsichtlich der Anforderungen an klinischen Daten in der EU, den Erwartungen und Anforderungen der Benannten Stelle oder der Frage wie Claims durch einschl?gige klinische Nachweise untermauert werden k?nnen? Ben?tigen Sie Unterstützung beim Entwurf einer Strategie für die systematische klinische Datenerhebung? Dann wenden Sie sich an AKRA TEAM oder LS medcap GmbH. ? ?#webinar #MDR #EU #ClinicalData #regulatoryaffairs #CE #medicaldevices

Noch wenige Tage bis zu unserem kostenfreien Webinar zu Sufficient Clinical Data. Jetzt noch hier anmelden: https://lnkd.in/ee5EHYgT

Online Training: ???????????????????? ???????????? ?????? ?????? ???????????????? ???????????????????? – ????????????????, ???????????????????????? ?????? ????????????????????, ???????????????? ???????????????? ?????? ???????? ?????? ??&?? ? ?? Several dates available for 2025! ???? ??????, ???? ??????, ???? ??????, ???? ?????? ?????????????? ????????????: ? Applicable legislation & guidelines ? Sources of literature & requirements ? Content details of the Literature Search Protocol (LSP) & Literature Search Report (LSR) ? Interlinks with the Clinical Evaluation ? Suggestions for a systematic & efficient, stepwise approach ? Notified Body Expectations ? ??????????????: Senior Consultant Dr. Ulla Gertig ? ?????????????? & ????????????????????????: https://lnkd.in/e9b-5yb7 ? #online #training #literaturesearch #regulatoryaffairs #medicaldevices #EU-MDR #LSP #LSR

Just Published: The NEW February Issue of "EU MDR & IVDR Insider" Download the "EU Orphan Device Clinical and Regulatory Playbook" ???? >> Featuring insights from Bassil Akra, Philippe Auclair, Steve Eglem, Stephen Gilbert, Ralf Klein, Tom Melvin, Marianna Mastroroberto, #DeCODe, and more. Click to expand to view and download. Subsribe to "EU MDR & IVDR Insider" (link in comments). #orphandevices #eumdr #rarediseases

Just Published: Feb. Issue of "EU MDR & IVDR Insider" from AKRA TEAM Download the "EU Orphan Device Clinical and Regulatory Playbook" ???? Featuring insights from Bassil Akra, Philippe Auclair, Steve Eglem, Stephen Gilbert, Ralf Klein, Tom Melvin, Marianna Mastroroberto, #DeCODe, and more. Expand to view and download. Subscribe to "EU MDR & IVDR Insider" (link in comments). #orphandevices #eumdr #rarediseases

Online Seminar/Training – Clinical Evaluation and Clinical Evidence for Medical Devices ?? 19 March 2025 ? Covered topics: ?Regulatory Framework for Clinical Evaluation ?Clinical Data and Clinical Evidence ?Clinical Evaluations and Clinical Investigations? ?Clinical Evaluation throughout Medical Device Lifecycle ?Real World Evidence ?How Clinical Evidence links to Risk Management, Biocompatibility, PMS ? The online seminar is presented by our Senior Consultant @Dr. Susanne Gerbl-Rieger, distinguished by her long-time experience working with one of the biggest notified bodies and in clinical research and regulatory consulting. ? Learn more and register now: https://lnkd.in/dfPFeQ6e ? #training #online #ClinicalEvaluation #regulatoryaffairs #clinicalaffairs #medicaldevices ?

Jetzt zum ?????????????? anmelden: ??????????????-?????????????????????? – ?????? ?????? ???????????????? ???? ?????????????????????? ?????? ???????????????????? ??????????? ?????? ?????????????????? ???? ???????????????????? ???????????????? ????????. ?? 12. M?rz 2025, 11:00-12:00 Uhr CET Sprache: Deutsch ? ???????????? ???? ü????????????????: ? Anforderungen an klinische Daten in der EU ? Wie Claims durch einschl?gige klinische Nachweise untermauert werden k?nnen ? Erwartungen und Anforderungen der Benannten Stelle ? Unterschiede zwischen klinischer Bewertung und klinischer Prüfung ? Entwurf einer Strategie für die systematische klinische Datenerhebung ? Klinische Prüfungen (Pre- und Post-Market) nach ISO 14155 und EU-MDR ? ??????????????: Dr. Bassil Akra und Natasa Mitrovic MSc ? ?????????????? ?????? ??????????????????: https://lnkd.in/ee5EHYgT ? #webinar #MDR #EU #ClinicalData #regulatoryaffairs #CE #medicaldevices

PMS, Vigilance & Reporting: What Could Go Wrong? Plenty. >> Register now, and please bring your questions: https://lnkd.in/g6bUWudd Please join us this Thursday with subject matter experts Milad Masjedi, Muna Kebede, Marta Carnielli, and Julia Hoyer?for a?live discussion?about: ???Why notified bodies reject PMS reports ???What manufacturers overlook in vigilance reporting ???How to streamline compliance under MDR & IVDR >> Webinar details ???Thursday, February 27, 2025 ??4 PM CET | 10 AM ET* ???Live & Free on Zoom (*Recording available to all participants) TüV SüD, SGS, MedTech Leading Voice

?????????? ????????????????: ?????? ???? ???????????????????????? ???????????????? ?????? ????????-???????????? ?????????????????????? ???????????????? ?????????????????? – ???????? ?????????????????????????? ?????? ?????????? ???????????????????????? ???????????? ???????? ? ?? ???? ?????????? ???????? or ???? ???????? ???????? ?? Newton Building, Ridlerstr. 57, 80339 Munich ? This one-day workshop provided by specialists of AKRA TEAM GmbH and Dr. Ebeling & Assoc. GmbH will provide a structured step-by-step approach, how the different legislations are to be considered and applied for different types of DDCs. ?????????????? ????????????: ? Definition / Wording / Nomenclature ? Types and variants of Devices, combining MDs & MPs ? Decision making process & stakeholders involved ? Overview & characteristics of different Drug-Device-Combination products ? Sources of information ? Processes involved ? Trainers: Dr. Bassil Akra, Dr. Julia Schiekel, Dr. Ross Lewin ? Details and registration: https://lnkd.in/eE4G_w47 ? #Workshop #DDCs #onsite #EU-MDR #regulatoryaffairs #medicaldevices #drug-device-combinations #training #pharma #article117 #Directive2001/83/EC?

It is still time to register last minute for our free webinar on ???? ?????? ?????????? ???????????????? ????????????????????????: https://lnkd.in/ehHRaBwV We look forward to many participants and discussions.