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About us

Company History

ACR Consulting & Talent Solutions was born out of a strategic initiative to fulfill an essential need for specialized staffing solutions within the MedTech sector, a vision conceived by Maria Nyakern, Ph.D. This initiative took shape following the successful establishment of AKRN Scientific Consulting in 2018, a prominent European medical device Contract Research Organization (CRO) that quickly rose to prominence under Maria’s leadership.

Welcome to Associates of Clinical & Regulatory (ACR) Consulting & Talent Solutions, an initiative launched by Maria Nyakern, Ph.D., following her leadership success at AKRN Scientific Consulting, a leading European medical device CRO established in 2018. Recognized for her pivotal role in regulatory and clinical development, Maria assembled a team of over 50 experts, demonstrating the need for specialized expertise in navigating MedTech’s regulatory complexities and clinical management.

ACR Consulting & Talent Solutions addresses the critical demand for skilled clinical research professionals in the MedTech sector, which continually faces challenges due to complex regulatory environments and a shortage of qualified staff. We provide a crucial link between MedTech companies and top-tier clinical research talent, offering comprehensive services including staffing support, project and clinical trial management, and regulatory assistance tailored to the MedTech industry.

As we grow, our mission remains steadfast: to equip MedTech organizations with the essential resources and expertise needed for innovative medical device development, ensuring quicker market entries and enhanced patient care.

Mission Statement

Associates of Clinical & Regulatory (ACR) Consulting & Talent Solutions is dedicated to empowering MedTech organizations by providing specialized staffing solutions, leveraging our commitment to excellence and innovation, to advance healthcare technology and improve patient outcomes.

Meet Our Team

At ACR Consulting & Talent Solutions, our leadership and professional team are at the core of our mission to revolutionize the MedTech industry by providing top-tier talent specifically tailored to the needs of our clients. Guided by a shared commitment to excellence and innovation, our team members bring a wealth of experience and expertise to support our clients in advancing healthcare technology and improving patient outcomes. Our company offers comprehensive solutions to meet the staffing requirements in clinical research and regulatory affairs. 

• Expertise in identifying high-quality scientific talent (e.g. biomedical scientists & engineers, pharmacists etc)

• Providing clinical & regulatory science associates with state-of-the-art ISO 14155, ISO 13485, and EU MDR 2017/745 training 

• Emphasis on tailored, client-specific talent solutions

Maria

Chief Executive Officer
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Aitana

Clinical & Regulatory Science Associate
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Andrea

Clinical Science Associate
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Our team at Associates of Clinical & Regulatory Consulting embodies the values of dedication, innovation, and excellence. We are committed to empowering our clients and the MedTech industry as a whole, paving the way for a future where healthcare technology continues to enhance patient care and outcomes.

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Who We Serve

At ACR, we are proud to partner with a diverse range of clients within the MedTech ecosystem. Our specialized services are tailored to meet the unique needs of our clients. By serving these key players in the MedTech field, ACR is committed to advancing the industry through collaboration, dedication to quality, and a shared vision of improving patient outcomes through technological progress

Medical Device Manufacturers

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Contract Research Organizations (CROs)

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Notified Bodies

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Sponsors

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Ready to Get Started?

Contact us here
ACR consulting logo

Calle Fernando el Santo 27

28010 Madrid, Spain

hello@acrconsulting.eu
+ 34 914 320 709
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Maria Nyakern

Ph.D. - CEO

As the founder and CEO of ACR Talent Solutions, Maria Nyakern, Ph.D., is a visionary leader with a profound background in the medical device industry. With the successful establishment of medical device CRO (AKRN Scientific Consulting), Maria has demonstrated an unwavering commitment to enhancing the MedTech sector. Her strategic foresight and dedication to innovation have positioned ACR Talent Solutions as a key player in providing specialized staffing solutions. Maria’s leadership is driven by a passion for empowering organizations to achieve groundbreaking advancements in healthcare technology.

Aitana

Clinical & Regulatory Science Associate

Aitana is a Clinical & Regulatory Science Associate with expertise in ISO 14155 and EU MDR 2017/745. She is also BSI ISO 13485 lead auditor certified. She has experience in CE mark compliance, clinical evaluation and clinical investigation management. Her analytical skills and proactive approach to problem-solving ensure that the research projects meet the highest quality standards. Aitana supports your team in translating regulatory requirements into actionable steps to ensure that your projects not only stay compliant but also are optimized for efficiency and accuracy.

Medical Device Manufacturers

We understand the critical role that manufacturers play in the lifecycle of medical devices. From innovative startups to established industry leaders, we provide skilled professionals who can support all stages of device development — from conceptual design through to post-market surveillance. Our team ensures that manufacturers can navigate the regulatory landscape with confidence and bring safe, effective medical devices to market.

Contract Research Organizations (CROs)

CROs are pivotal in the execution of clinical trials, and our staffing solutions support these organizations by providing experienced clinical research associates, project managers, and regulatory experts. We enable CROs to scale their teams efficiently, ensuring that trials are conducted with the utmost rigor and adherence to regulatory standards.

Notified Bodies

For notified bodies, the demand for comprehensive expertise in regulatory compliance is paramount. Our professionals are well-versed in European regulatory frameworks and are equipped to support notified bodies in their critical role of ensuring medical devices meet the necessary safety and performance requirements.

Sponsors

Sponsors of clinical trials and research projects can leverage our staffing services to fill expertise gaps in their teams. We provide access to specialists who are not only experienced in the MedTech field but who also bring a fresh perspective and specialized knowledge to help sponsors achieve their project goals and drive innovation.