Designing for regulatory compliance
Overcoming regulatory barriers
Regulatory Path Under Control
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Get in touchWe conduct comprehensive Clinical Evaluation (CEP/CER) and Performance Evaluation activities, as well as provide support in managing clinical investigations, in full compliance with MDCG guidelines. Our service includes literature reviews, equivalence assessments, support in drafting clinical investigation protocols, management of clinical investigations, data collection, and the development of PMCF plans.
Read MoreWe prepare the documentation and manage the entire process required by ISO 14971 for risk management from the earliest design stages, including information security (cybersecurity) management. We support the manufacturer from the initial identification of risks, working alongside and training R&D personnel throughout the process.
Read MoreWe carry out comprehensive Biological Evaluations (BEP/BER), supporting the manufacturer from the early stages of product development by defining the biological evaluation strategy in accordance with ISO 10993-1 and major international guidelines (FDA). We also provide support in the execution and management of testing activities to ensure compliance of medical devices (MDR) and in vitro diagnostic devices (IVDR).
Read MoreWe support the validation of software for MDs and IVDs (embedded, standalone, apps, AI-based software, etc.) from the early stages of design in accordance with IEC 62304, integrating information security (cybersecurity) management following IEC 80001-5-1 and key MDCG and FDA guidelines, including those specific to Artificial Intelligence.
Read MoreWe prepare the documentation and manage the entire process required by IEC 62366 for usability validation, supporting the manufacturer from the initial identification of usability requirements through to summative validation.
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