Über uns

Who we are

We offer a wide range of service to support the various stakeholders on their pathway towards compliance.

AKRA TEAM is a consultancy company which was founded in 2021 by Dr. Bassil Akra to support various healthcare system stakeholders in 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 legal obligations. AKRA TEAM was established to make a difference and ensure that patients receive safe and effective devices in a timely manner.

Feature Listing

Training and Education
Preparation of regulatory strategy
Coaching and Project Management
Development of a Quality Management System
Drafting of procedures and templates
Writing of technical documentation including clinical or performance evaluation
Readiness Check
Preparation, Internal and Supplier Audit
Selection of Notified Bodies
Selection of designated competent authorities for drug device consultation
Communication with regulators and notified bodies
Support during Clinical (Performance) Evaluation Consultation

Our Partners

Obelis

Obelis is the largest center in Europe for CE Marking, European Representation and European Authorized Representative services (EC REP). With 35 years of business experience, we have helped more than 3,000 manufacturers from over 70 countries to safely place their products on the EU market. We are ISO 9001 & ISO 13485 certified, and we are members of EU Associations and EU Commission Working Groups.

Obelis und AKRA TEAM exchange expertise and knowledge in the field of the MDR & IVDR, enabling medical device manufacturers to safely transition and become compliant with the medical device legislation.

MDlaw

MDlaw, Information Platform on EU Medical Device Regulations offers a system that helps you identify and monitor all the relevant regulatory requirements and changes, as per ISO 13485:2016. MDlaw is the one place where you can find all regulatory documents, guidelines, case-law and updates, gathered and published right after their release.

meddevo

meddevo eTD is a regulatory software solution for automating technical documentation, country registrations and digitalization of regulatory processes for medical devices and IVDs. Create a single source of truth and manage your technical documentation with the latest regulatory affairs technology to accelerate market access and control your document lifecycle. The combination of AKRA TEAM's expertise and meddevo's latest technology creates innovative solutions.

DistillerSR

DistillerSR® Inc. is the market leader in AI-enabled literature review automation software and creator of DistillerSR. Today, more than 300 of the world’s leading research organizations, including more than 70 percent of the top 10 pharmaceutical and medical device companies, trust DistillerSR to produce transparent, audit-ready, and regulatory-compliant literature reviews.

The partnership combines DistillerSR’s market leading literature review management platform with the AKRA TEAM’s extensive expertise in literature search methodology; the outcome is faster and more accurate regulatory submission reports.

InSilicoTrials

InSilicoTrials is an emerging startup founded in 2018 by a team of life science, cybersecurity and digital innovation experts, which aims to revolutionize Healthcare through an innovative digital simulation platform, where complex computational models run in an easy and cost-effective way to hyper- accelerate drug & medical device development. We offer Pharma and MedTech companies state-of-the-art simulation tools that can increase the quality of life of millions of patients by allowing cheaper treatments and bringing innovative drugs to the market faster.

InSilicoTrials and the AKRA TEAM share a common vision to make a difference in patients’ lives and to boost the world’s transition to accessible therapies.

Meditrial

Meditrial is a full services Clinical Research Organization (CRO) focused on the medical device industry's needs, and we are proud to serve the world's most innovative life sciences companies. Meditrial drives expected performance and acceleration by employing our digital platform to reach milestones with simplicity, speed, and efficiency, backed by our proprietary cloud-based software solutions designed to minimize complexity, manage large trial results, and ensure medical device development, launch, and adoption efficiency.

Together with AKRA TEAM, Meditrial is dedicated to providing the latest innovators with the guidance needed to achieve their definition of success.

Dr. Ebeling & Assoc. GmbH

Dr. Ebeling & Assoc. GmbH is a service provider for the health care industry with a focus on medical writing and vigilance. We offer pharma and medical device companies a wide range of services in the scientific, medical, regulatory, quality and compliance sector. Our medical device expert team offers support and consulting for manufacturers of substance-based/not substance based MDs and IVDs to ensure compliance with the MDR/IVDR.

AKRA Team GmbH and Dr. Ebeling & Assoc. GmbH cooperate in the field drug/device combination products to allow a synergistic optimisation of (e)CTD – MDR/IVDR-related documents with respect to developmental and regulatory strategies.

Use-Lab GmbH

Seit 2001 bietet Use-Lab als unabhängiges Dienstleistungsunternehmen professionelle und individuelle Beratung im Bereich des Usability Engineering und User-Interface Design für Hersteller von Medizinprodukten, Laborgeräten und In-vitro-Diagnostika an. Unser interdisziplinäres Team unterstützt Sie zielgerichtet und objektiv bei der Entwicklung und Evaluierung von Produkten für den Gesundheitssektor. Unser Dienstleistungsportfolio reicht von Anforderungsanalysen, über formative und summative Studienorganisation und -durchführung bis hin zu speziellen Schulungsseminaren und Dokumentenchecks.

Mit der erweiterten regulativen Expertise des AKRA TEAMS und der langjährigen praktischen Erfahrung von Use-Lab tragen wir zu unserer gemeinsamen Vision bei, eine sichere und effektive Nutzung von Medizingeräten zu gewährleisten und somit die Patientensicherheit zu maximieren.

Explic8

Explic8 Consulting is a management consulting company offering specialty expertise focussing on medical device and pharmaceutical industries. Explic8 have a track record of providing objective, hands-on, highly skilled, and holistic consulting support to senior leaders in leading, managing, and executing innovative projects in life sciences that deliver value efficiently for our clients.

Über uns

Who we are

We offer a wide range of service to support the various stakeholders on their pathway towards compliance.

Feature Listing

Our Team

Dr. Bassil Akra

Dr. Andrew Gibson

Dr. Fabienne Neibecker

Prof. Dr. Markus Balkenhol

Muna Kebede

Dr. Matthias Fink

Dr. Susanna Kerschl

Dr. Leslie Hammermüller

Dr. Ulla Gertig

Ema Omeragić Zaimović

Dr. Anna Spehl

Amith Vijayakumar

Lawrence Yeh

Hilola Hakimova

Dr. Susanne Gerbl-Rieger

Norchéne BenMadhi

Monica Ceruti

Andrea Beaujean

Anna Kristina Cachia

Jillan Hussein