The company provides specialized technological and strategic consulting services for the MedTech industry, with a focus on product development, regulatory compliance, and M&A process optimization. We support leading European MedTech organizations in areas such as technology due diligence, risk evaluation, and integration planning, influencing over 500 million PLN in acquired entities’ revenue. Our deep knowledge of IEC 60601, ISO 13485, and portfolio M&A enables seamless technical integration and robust risk mitigation throughout the acquisition lifecycle.

With a strong foundation in governance frameworks and development processes, the company has designed and implemented over 50 operational governance structures, including Stage-Gate NPD systems, Portfolio Management workflows, and Risk-Based Design Control strategies. These have significantly improved product lifecycle efficiency and traceability. Our technical expertise in IEC 62304 and ISO 14971 supports the development of compliant, safe, and high-performing medical devices through effective risk-based design practices.

The company has provided end-to-end consulting for four large-scale NPD programs, each involving complex assemblies of over 800 BOM components. Through comprehensive design reviews, we have helped clients enhance functional performance, system integration, and long-term reliability.

We also conduct advanced market and technical feasibility studies that have enabled startups to secure venture capital and achieve successful market entry in Europe. Our experience in innovation funding, product portfolio assessments, and regulatory due diligence helps clients identify high-potential opportunities while ensuring compliance with evolving standards.

In addition, the company has led the implementation and optimization of Quality Management Systems (QMS) for over five organizations, with a focus on CAPA systems, internal audits, and regulatory readiness.

Our strategic support extends to complex regulatory pathways, including Software as a Medical Device (SaMD) and reimbursement strategies, helping reduce time-to-registration by up to 30%. We also advise on outsourcing models, interim technical management, and scaling operations under MDR and IVDR requirements.

With a deep understanding of MedTech-specific engineering, regulatory, and commercial environments, the company helps clients overcome technological and compliance challenges, accelerate innovation, and achieve sustainable market success.