Designing for Regulatory Compliance
Every stage of the regulatory pathway is managed from the very beginning of product development
Every stage of the regulatory pathway is managed from the very beginning of product development.
To design medical devices (MDs) or in vitro diagnostic devices (IVDs) in compliance with applicable regulations, it is essential to follow the principles established by international regulatory frameworks (e.g., MDR 2017/745, IVDR 2017/746, 21 CFR 820, etc.) and to manage design activities within a Quality Management System (QMS) compliant with ISO 13485.
This system covers all stages of the product life cycle — from design to post-market activities — enabling the preparation of a Technical Documentation package that includes, for example, clinical evaluation and risk management documentation, biological evaluation, software validation, and other essential components to certify or register the product in the manufacturer’s target international markets.
With a team of clinical, technical, and regulatory experts experienced in the development of both conventional and innovative products, Maytal supports manufacturers from the earliest phases of product development, ensuring that every step of the regulatory process is controlled from the outset.
This proactive approach minimizes time to market and avoids inefficiencies commonly associated with non–compliance-oriented design processes.
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Clinical and Performance Evaluation
We 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.
Risk Management: ISO 14971
We 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.
Biological Evaluation
We 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).
Software and AI Validation
We 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.
Usability Validation
We 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.