CONSULTING seleon GmbH

Engineering and regulatory consulting for safety-critical medical device development, including system architecture design, quality management, regulatory affairs support, and comprehensive testing and optimization services.

Medical consulting services specializing in research, development, production, and commercialization strategy for medical devices and diagnostic equipment. Provides comprehensive enterprise solutions integrating product development, scientific research, and market implementation for healthcare organizations.

Consulting services for embedded software development and systems integration in medical devices. Provides bespoke software engineering, testing, compliance support, and technical expertise to accelerate product development across medical, diagnostic, and biopharmaceutical applications.

Regulatory, clinical, and quality consulting services for medical devices, in vitro diagnostics, and software-as-a-medical-device (SaMD). Supports CE marking and FDA approval pathways, quality system implementation (ISO 15189, ISO 17025), and compliance with MDR 2017/745, IVDR 2017/746, and 21 CFR standards. Services include regulatory strategy design, requirement analysis, and market authorization across the product lifecycle.

Professional consulting services for medical device regulatory compliance and business strategy. Supports manufacturers in meeting international standards and regulatory requirements.

Regulatory consulting and software solutions enabling medical device manufacturers to navigate compliance requirements and accelerate market entry. Supports device classification, documentation, and regulatory strategy across EU and international markets.

Medical device design and engineering consultancy providing full product development services including mechanical design, electronics, human factors, and regulatory support for medtech and pharmaceutical companies. Delivers concept-to-commercialization solutions with design control expertise and manufacturing knowledge.

Expert medical device design and development consultancy providing full-cycle engineering services including mechanical design, electronics, human factors, and regulatory compliance. Supports medtech and pharmaceutical companies from concept through manufacturing to accelerate product development and market entry.

Professional consultation services for medical device selection and clinical implementation. Provides technical guidance for healthcare facility optimization.

Legal and regulatory compliance consulting for medical device registration, approval pathways, and post-market surveillance requirements across different regulatory jurisdictions.

Regulatory and quality management consulting for medical device development and MDR compliance. Supports companies through risk assessment, market requirements analysis, CE marking processes, and digital documentation systems to ensure safety and regulatory adherence.

Professional consulting services for medical device development, material selection, and manufacturing process optimization. Leverages 25+ years of expertise in quality-focused medical device production.