AKRA TEAM Service Solutions
Consulting | Writing | Auditing | Training
Your Experts for Regulatory, Quality and Clinical Affairs.
We offer a wide range of service to support various stakeholders on their pathway towards compliance.
Consulting
Professional and Strategic
Our leading team of experts at AKRA TEAM offers support with all major global jurisdictions including EU, US, UK, Switzerland and other global markets. AKRA TEAM is a full-service consultancy providing a wide range of services including:
- Clinical Strategy
- Regulatory Strategy
- Post-Market Strategy
- Market Authorisation
- Remediation Support
- Compliance Support
- Ad-hoc Consultancy Support
MONTHLY FEES – FULL YEAR BENEFITS
SUBSCRIPTION-BASED CONSULTING: YOUR MEDICAL DEVICE SOLUTIONS ON-DEMAND
Access Expert Guidance When You Need It Most.
In the fast-paced world of medical device and diagnostic manufacturing, challenges don’t arrive on a schedule. Our innovative subscription model gives you dedicated consulting hours at your fingertips – ready when you need them, without the stress of unexpected costs.
“Pay monthly, benefit annually” – predictable expenses with maximum flexibility.
CHOOSE YOUR PERFECT FIT:
Essential
Advanced
Premium
Perfect for emerging companies or specific project needs:
Our most popular option for growing manufacturers:
Comprehensive support for established operations:
- Dedicated consulting hours to use at your own pace
- Full access to our expertise when you need it
- Predictable monthly investment
- Increased yearly hour allocation
- Priority scheduling with our consultants
- Quarterly strategy check-ins
- Maximum flexibility with our highest hour allocation
- Guaranteed 48-hour response time
- Dedicated senior consultant
- Annual strategic planning session
- Quarterly strategy check-ins
- Access to monthly
- Compliance Café live online sessions
- Regulatory Check-in recorded sessions
- Access to VOD training library
- Discounted subscription renewal
Same as in the Essential package,
plus:
- Discounted access to our Trainings & Events
- Complimentary access to 3 Trainings per year, to select from our Training Portfolio or Accelerator Programs
- Discounted access to
- TOM’s Mentorship
- Tailored Training Solutions
60h
120h
240h
WHY SUBSCRIBE?
- Budget Certainty: Transform variable consulting costs into predictable monthly expenses
- Immediate Access: No lengthy procurement processes when urgent needs arise
- Relationship Continuity: Work with consultants who understand your products and processes
- Flexible Application: Apply your hours to any service in our portfolio as needs change
- Simplified Administration: One agreement, one invoice, unlimited possibilities
HOW IT WORKS
- Select the subscription tier that fits your anticipated needs
- Your dedicated hours become available immediately
- Request support whenever challenges arise
- Adjust your subscription level as your requirements evolve
Contact
Ready to bring predictability to your medical device consulting needs? Contact us today for a personalized consultation and discover how our subscription model can transform your approach to expert support.
Learn more about our dedicated services.
Overview
Move beyond one-way, slide-deck driven events and break the mold with the Quality Accelerator Program — a groundbreaking two-day immersive experience designed exclusively for medical device and diagnostic professionals who want to develop a problem-solving mindset and stay ahead of the curve.
Unlike conventional conferences, this program replaces passive listening with active, hands-on learning through intensive workshops, collaborative brainstorming, and dynamic knowledge-sharing sessions. Theoretical content is strategically delivered via pre-event video-on-demand, allowing participants to arrive primed for deep engagement. More than just a conference, this is a career-defining opportunity to network with industry peers, forge powerful professional connections, and establish yourself as a go-to expert in quality management within your organization. By participating, you’ll not only gain cutting-edge insights but also position yourself as a thought leader who can drive innovation and excellence in medical device quality.
Net price
Net price
€ 1,250.-
- 2 Days onsite event
- Workshop and experience exchange
- Interactive exercises
- Excellent networking opportunity
- Catering: Coffee breaks and lunch incl.
WRITING
Predictable and Compliant
AKRA TEAM offers the development and writing of clinical, regulatory and quality documentation for EU and/or US strategy.
- Clinical (Performance) Evaluation Documentation, including execution of the literature searches in key databases.
- Drafting and regular update of various reports including but not limited to CEP, PEP, CER, PER, PSUR, SS(C)P, etc.
- Analysis of all relevant data and development of compliant PMS Plan including PMC(P)F Plan.
- Writing of the Technical Documentation and support in the planning of pre-clinical testing.
- FDA: Drafting of 510(k)s, PMAs, Q-Sub, 513(g) requests, including relevant documentation.
- Study Protocol and Report for pre- or post-market Clinical Investigation (Performance Study).
Contact
AKRA TEAM has an experienced team of medical writers, clinicians and regulatory experts available to write all aspects of technical documentation for all device categories and risk-classes. We offer custom tailored solutions or comprehensive solutions to addresses the needs of any manufacturer. Additionally, if the technical documentation is currently under review we can provide targeted updates based on any open deficiencies.
AUDITING
Internal and Supplier Audits
AKRA TEAM offers a variety of audit and assessment services to ensure readiness of clinical, quality and regulatory documentation, including but not limited to:
- Internal Audits of the QMS against various standards and regulations (e.g., ISO 13485, MDR, IVDR, ISO 14155, MDSAP, etc.)
- External Audits of critical suppliers and processes
- Readiness Checks against new requirements such as MDR and/or IVDR provisions to prepare for audits and inspections
- Technical Documentation and Clinical Evaluation Assessment
Contact
From our specialized team covering all regulatory, clinical and quality topics, to our track record of success, we will be happy to support customer requests.
Training
Tailor made and interactive
At AKRA TEAM, we design custom training programs that address your medical device and diagnostic company’s specific knowledge needs across the entire product lifecycle.
Our specialized programs cover regulatory compliance, clinical affairs, quality systems, technical documentation, post-market surveillance, risk management, and more – precisely tailored to your team’s requirements.
More Than Training – A Partnership for Success
When you entrust your team’s development to us, you’re not just booking a training session – you’re gaining a committed partner invested in your success. We take time to understand your specific challenges, knowledge gaps, and strategic objectives before crafting learning experiences that deliver measurable impact.
CUSTOM-BUILT FOR YOU
Each program addresses your specific challenges and objectives
INDUSTRY EXPERT INSTRUCTORS
Learn from seasoned medtech professionals
INTERACTIVE & PRACTICAL
Application-focused learning that transforms knowledge into actionable skills
FLEXIBLE DELIVERY OPTIONS
In-person, virtual, or hybrid formats
Upcoming Trainings and Webinars
We don’t just deliver information – we ensure your people gain the knowledge and skills to excel in today’s complex medtech landscape.
Ready to elevate your team’s capabilities? Discover our upcoming trainigs and events or contact us to discuss your training needs.
THE TOM MENTORSHIP
TRAINING | ONBOARDING | MAINTAINING
Meet TOM – Your Partner in Medical Device & Diagnostic Excellence
Starting in regulatory, quality, or clinical roles can be overwhelming. Complex regulations, specialized terminology, and high-stakes responsibilities await. That’s why we created TOM – not just another corporate initiative, but a trusted companion who walks beside your junior staff from day one.
WHY TOM MATTERS
Junior professionals in medical devices and diagnostics face unique challenges:
- Navigating complex regulatory frameworks
- Understanding quality systems that ensure patient safety
- Building confidence in high-stakes decision-making
TOM transforms overwhelmed newcomers into confident contributors through personalized support exactly when they need it.
HOW TOM HELPS
- Training: Targeted knowledge transfer tailored to your specific products and regulatory environment.
- Onboarding: Accelerated integration into your team with guided immersion in critical systems and processes.
- Maintaining: Ongoing mentorship and development that continues long after the initial training period.
THE BENEFITS
FOR COMPANIES
- Reduces time-to-productivity
- Decreases early turnover of promising talent
- Ensures regulatory compliance through consistent knowledge transfer
FOR JUNIOR STAFF
- Never navigate complex regulations alone
- Build confidence through structured support
- Develop specialized skills that accelerate career growth
Contact
INVEST IN TOMORROW’S LEADERS TODAY
TOM isn’t just a mentorship initiative – it’s your insurance policy for regulatory excellence and talent retention. Contact us today to bring TOM to your organization.
The Team
Why
AKRA TEAM
SPECIALISED EXPERTISE
Special matter experts in Regulatory, Clinical and Quality who worked for manufactuers and notified bodies with cumulated experience of +250 years.
INVOLVEMENT IN REGULATIONS IMPLEMENTATION
Contribution in implementation of medical device regulation in Europe, drafting European guidance documents and International Standards.
MEMBERSHIPS IN BOARDS
Various memberships in advisory boards and planning committees.
Our diverse and deep experience, expertise and activities seize our influence, involvement and contribution to current legislation and hence exceptional knowledge about current requirements and upcoming changes. Our activities in supporting various stakeholders to achieve their targets in the healthcare industry ensure continuity of the healthcare system in the interest of patient populations.
Downloads
Customers Worldwide
Years of Experience
Completed Projects
LinkedIn Follower
The Team
Our creative team
Services
We use unique, custom-built tools to give us the edge
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Strategy planning
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Questions?
Natasa Mitrovic, M. Sc.
Director Clinical Affairs
LS medcap GmbH
Frau Mitrovic ist eine erfahrene Expertin für klinische Forschung mit mehr als einem Jahrzehnt Erfahrung in der Leitung nationaler und internationaler klinischer Studien für Medizinprodukte der Klassen I-III. Sie begann ihre Karriere als Krankenschwester und sammelte 17 Jahre Erfahrung in der Kardiologie, Angiologie und Elektrophysiologie, bevor sie in die klinische Forschung wechselte.
Nach ihrer Tätigkeit als Studienkoordinatorin im universitären Umfeld wechselte sie in die Medizinprodukte-Industrie. Sie hatte Schlüsselpositionen bei weltweit anerkannten Unternehmen inne, die auf kardiovaskuläre Technologien spezialisiert sind, wo sie klinische Studien leitete und die Einhaltung gesetzlicher Vorschriften sicherstellte.
Seit 2019 ist sie als Director Clinical Affairs bei der LS medcap GmbH tätig, wo sie klinische Forschungsinitiativen leitet, die regulatorische Strategie überwacht und mit interdisziplinären Teams zusammenarbeitet, um Innovationen in der Medizintechnik voranzutreiben. Sie hat einen M.Sc. in klinischer Forschung (mit Auszeichnung) und erweiterte Qualifikationen in klinischer Studienüberwachung und DM.
Dr. Bassil Akra ist Geschäftsführer und Inhaber der AKRA TEAM GmbH. Dr. Akra war Vizepräsident für strategische Geschäftsentwicklung bei den Global Medical Health Services der TÜV SÜD Product Service GmbH. Er verfügt über umfangreiche Erfahrung in den Bereichen Leadership, Unternehmensführung, Forschung, Entwicklung und Qualitätsmanagement, sowie behördliche Zulassung von Medizinprodukten, Kombinationsprodukten und ATMP-Produkten. Dr. Akra spielte eine wesentliche Rolle bei der Umsetzung der Medizinprodukteverordnung in Europa. Er war auch an der Ausarbeitung mehrerer europäischer Leitfäden (z. B. MEDDEV, MDCG usw.) und internationaler Standards beteiligt. Die letzten Jahre seiner Karriere verbrachte er bei TÜV SÜD, wo er verschiedene Interessengruppen in EU-Rechtsvorschriften (z. B. MDD/AIMDD, MDR und IVDR) schulte und ihre Umsetzung unterstützte, um eine entsprechende Kennzeichnung zu erreichen und die Kontinuität des Gesundheitssystems im Interesse der Patientengruppen sicherzustellen.
Prof. Tobias Walker
Chief Medical Officer
LS medcap GmbH
More upcoming trainings and webinars
Support & Training
You have not found the right training for you and you would be interested in an offer for a specific and customized training on another topic in the field of regulatory affairs? Or you are interested in support and hands on implementation services?