Asphalion, S.L.

Spain

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Asphalion, S.L. is an international scientific, safety, and regulatory affairs consultancy founded in 2000 and headquartered in Barcelona, Spain, with additional offices in Madrid, London, and Munich. The firm provides end-to-end regulatory engineering and strategic support for medical technologies, pharmaceuticals, and biotechnology developers.

Asphalion assists medical device and in vitro diagnostic (IVD) manufacturers in achieving compliance with European and global regulatory regimes, specializing in design-level regulatory strategy, technical file construction, risk management, and regulatory authority submissions.

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Asphalion provides comprehensive regulatory affairs and compliance consulting tailored to medical devices, IVDs, and software as a medical device (SaMD):

European CE Marking (MDR/IVDR): Preparation and remediation of technical documentation files according to EU MDR 2017/745 and IVDR 2017/746, classification strategy, General Safety and Performance Requirements (GSPR) checklist completion, and Notified Body interaction.
US FDA Pathways: Strategy and dossier preparation for 510(k) Premarket Notifications, De Novo classifications, Premarket Approvals (PMA), and Pre-Submissions (Q-Sub).
Risk Management & Usability: Implementation of risk management systems compliant with ISO 14971:2019 and usability engineering documentation under IEC 62366-1.
Quality Management Systems (QMS): Design, implementation, and audit support for ISO 13485 and MDSAP (Medical Device Single Audit Program) requirements.
Clinical Evaluation & Documentation: Clinical Evaluation Plans (CEP) and Reports (CER), Performance Evaluation Reports (PER), Post-Market Surveillance (PMS), and Periodic Safety Update Reports (PSUR).

Asphalion, S.L.

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