KB Quality & Compliance

KB Quality & Compliance is a specialist consulting service providing expert Quality Assurance, Quality Control, and Regulatory Affairs services to medical device companies and industrial sectors. The company is led by Kety Bardugo, an experienced quality, regulatory, and operations leader with more than 18 years of expertise in these complex fields, ensuring product safety, market approvals, and optimal efficiency. Core Services: ✔ Regulatory Compliance – Ensuring adherence to ISO 13485, ISO 9001, GMP, ISO 62304, MDR, and FDA 21 CFR Part 820. ✔ Accelerated Market Access – Supporting FDA 510(k), PMA, and EU MDR submissions to help companies bring products to market faster. ✔ Optimized Quality Systems – Implementing, maintaining, and optimizing QMS frameworks to enhance operational efficiency. ✔ Risk Management & Supplier Audits – Conducting supplier evaluations, qualification audits, and risk assessments to minimize compliance risks. ✔ Cross-Functional Leadership – Collaborating with R&D, production, and executive teams to align regulatory strategies with business goals. ✔ Manufacturing Operations – Transitioning from development to full-scale production ✔ ERP & Documentation Control – System integration and regulatory data management KB Quality & Compliance provides tailored consulting solutions specifically customized to meet the unique needs of each client, from startups to established firms. Kety Bardugo has a strong track record of successful regulatory approvals and QMS implementations based on in-depth industry expertise across multiple markets. As a result, the company also benefits from an excellent global network, enabling seamless collaboration with regulatory bodies, notified bodies, and medical device manufacturers around the world.

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