Everything you need to prepare your device for successful market entry.
Regulatory and quality requirements during product design and development can be demanding. We help define your regulatory pathway, clinical strategy, risk management activities, and reimbursement approach while preparing submission-ready technical documentation.
Cybersecurity and privacy are essential for digital health solutions. We support threat modelling, secure development, IEC 81001-5-1 implementation, FDA documentation, vulnerability management, DPIAs, and privacy management.
Digital healthcare solutions rely on health data throughout development, testing, and use. We support data governance, traceability, integrity, supplier controls, GDPR, EHDS, and AI Act compliance.
We support compliant software development and maintenance through the product lifecycle, including IEC 62304, risk management, cybersecurity, change control, traceability, and verification, validation, and testing.
We implement management systems for quality, information security, and AI, including ISO 13485, MDSAP, ISO/IEC 42001, ISO/IEC 27001, and NEN 7510-1, with audits, training, management reviews, and practical procedures. We support interim quality roles.
We support international registration pathways for MDR, IVDR, FDA, and Health Canada, including device classification, documentation, submission planning, and coordination.
Everything you need to maintain compliance throughout your product’s market lifecycle.
Our MDIS platform helps economic operators manage regulatory obligations across the entire supply chain. It also supports automated registration activities within regulatory databases such as EUDAMED.
Entering new regulatory markets often requires registration in EUDAMED and other databases. We help simplify registration activities, address regulatory challenges, and support complete submission requirements.
Evaluate regulatory, quality, and operational readiness before key business decisions. We help identify compliance gaps, assess technical documentation, review regulatory status, and highlight potential risks associated with medical devices, software, and AI-enabled products.
Effective management systems depend on regular audits. Our services include internal audits, supplier audits, due diligence assessments, FDA mock audits, MDR/IVDR quality audits, ISO 13485, ISO/IEC 27001, NEN 7510-1 audits, and external certification support.
Regulatory and quality compliance continues after market approval. We support regulatory strategy, clinical planning, risk management, and technical documentation activities required throughout the post-market phase.
Our experienced team provides interim professionals for critical compliance functions, including Data Protection Officers (DPOs), Persons Responsible for Regulatory Compliance (PRRCs), and Quality, Regulatory, and Information Security specialists.
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