Alberto Paduanelli, BSc

Alberto Paduanelli is a senior quality and regulatory expert with over 28 years of international experience across medical device development, certification, and regulatory strategy. With a background in electronics engineering and deep specialization in active and software-driven medical technologies, he has built a reputation for navigating complex regulatory pathways with precision and authority.

As Founder of ALPA Medical, Alberto supports manufacturers worldwide in achieving and maintaining compliance across ISO 13485, MDR (EU 2017/745), MDSAP. His work spans the full product lifecycle, from early-stage regulatory strategy and design control through to technical documentation, clinical evaluation, post-market surveillance, and global market access.

Alberto has held senior roles within leading Notified Bodies and certification organizations, including TÜV SÜD, SGS, GMED, and NSAI, where he has acted as Lead Auditor, Auditor evaluator, Trainer, and Technical File Reviewer. In these roles, he has assessed a broad range of Class I to Class III devices, with particular expertise in active medical devices, software, and complex electromechanical systems .

Known for his rigorous, detail-driven approach, Alberto brings a unique dual perspective—combining the expectations of regulators and Notified Bodies with the practical realities faced by manufacturers. His advisory work focuses on de-risking regulatory pathways, strengthening quality systems, and ensuring that innovation translates into compliant, market-ready products.

At BioDesign, Alberto provides strategic oversight on quality and regulatory matters, ensuring that devices such as STiK™ Syringe Assist and SkinClip™ are developed in alignment with global regulatory expectations while remaining practical, safe, and effective for real-world use