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
AKRA TEAM
医疗设备制造业
Landsberg，Bavaria 3,015 位关注者
We make a difference and ensure that patients receive safe and effective devices in a timely manner.
关于我们
AKRA TEAM is a consultancy company which was founded in 2021 by Dr. Bassil Akra to support the various stakeholders in the healthcare system achieving their target in a highly regulated business area. The focus of AKRA TEAM is to support medical device, in-vitro diagnostic and combination device innovators, companies, notified bodies and regulators finding a practical and reasonable approach to fulfill their legal obligations. AKRA TEAM was established to make a difference and ensure that patients receive safe and effective devices in a timely manner.
- 网站
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https://www.akrateam.com
AKRA TEAM的外部链接
- 所属行业
- 医疗设备制造业
- 规模
- 11-50 人
- 总部
- Landsberg，Bavaria
- 类型
- 私人持股
- 创立
- 2021
地点
AKRA TEAM员工
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Lawrence Yeh
Quality Management Systems | Medical Devices | ISO 13485 | EU MDR | MDSAP
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Matthias Fink
Consultant for Medical Devices | Orthopedic Surgeon | AKRA TEAM | EU MDR | Clinical Data | FDA | Clinical Investigations| Regulatory
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Alexia Lynch
Event Production & Community Engagement
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Bassil Akra
Executive Regulatory and Quality Consultant & Trainer | MDR | IVDR | Combination Devices | Clinical | Conformity Assessment Support
动态
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Noch wenige Tage bis zu unserem kostenfreien Webinar zu Sufficient Clinical Data. Jetzt noch hier anmelden: https://lnkd.in/ee5EHYgT
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
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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
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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
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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
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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 ?
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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
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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
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?????????? ????????????????: ?????? ???? ???????????????????????? ???????????????? ?????? ????????-???????????? ?????????????????????? ???????????????? ?????????????????? – ???????? ?????????????????????????? ?????? ?????????? ???????????????????????? ???????????? ???????? ? ?? ???? ?????????? ???????? 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?
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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.
??????????????: ???? ?????? ?????????? ???????????????? ???????????????????????? – ?????? ???? ???????????????? ???????????????? ?????????????????????????? ???????? ?????? ???? ?????????????? ?? Tuesday, 25 February 2025 ? Register to our free webinar given by AKRA TEAM GmbH and ?????????? ?????? with regulatory professionals Dr. Leslie Hammermüller, Andrew Gibson, PhD, RAC and Junsheng (Johnson) Yang, providing a comprehensive understanding of the clinical data requirements necessary to support successful CE marking submissions under current European regulations and the options and requirements when considering to collect this data in China. ?????????????? ???? ?????? ?????????????? Participants will get: ? An overview of European clinical data requirements for CE marking ? Insights into the opportunities for conducting clinical investigations in China to meet these requirements ? A detailed discussion of data transferability considerations and the regulatory prerequisites involved ? Exploration of time and cost advantages associated with clinical data collection in China ? Details and registration: https://lnkd.in/ehHRaBwV #webinar #MDR #EU #China #regulatoryaffairs #CE #clinicalinvestigation
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