Bringing a device to market requires a clear regulatory pathway. We provide strategic guidance and technical documentation to help companies navigate, for example, FDA, MDR, UKCA, and other regulatory requirements.
We provide regulatory gap analysis, compliance roadmaps, technical file preparation, submission support (510(k), CE marking, UKCA), and Notified Body liaison—ensuring a smooth approval process.
Device compliance demands rigorous risk assessment to ensure safety and regulatory approval. In medical, for example, we integrate ISO 14971-compliant risk management into every stage of development.
We provide risk analysis workshops, Failure Mode and Effects Analysis (FMEA), hazard identification (HAZID), risk mitigation strategies, and usability risk assessments—ensuring safety is built into your device.
Regulated devices must adhere to strict lifecycle requirements. We ensure compliance with IEC 62304 for both embedded and standalone medical software, helping manufacturers meet safety and performance standards.
We provide software development lifecycle documentation, software classification analysis, verification & validation (V&V), cybersecurity risk assessment, and automated testing solutions—ensuring software meets regulatory and functional requirements.
Medical electronics must comply with IEC 60601-1 and IEC 60601-1-2 to ensure electrical safety, electromagnetic compatibility (EMC), and reliability in clinical environments.
We provide pre-compliance testing, design reviews for safety and EMC, insulation & leakage current analysis, fault condition testing, and preparation for accredited lab certification—reducing the risk of delays and failures in certification.
Compliance shouldn’t be an afterthought. We integrate regulatory considerations into design to reduce delays, minimize compliance risks, and ensure a smoother approval process.
We provide design reviews for regulatory alignment, technical documentation preparation, pre-certification testing (EMC, safety, usability), and regulatory submission readiness assessments—ensuring devices meet standards before full testing.
Regulations evolve, and post-market compliance is just as critical as pre-market approval. We help medical device companies monitor performance, manage risks, and stay up to date with regulatory changes.
We provide post-market surveillance strategy, complaint handling system setup, CAPA (Corrective and Preventive Actions) compliance, software update regulatory assessment, and vigilance reporting support—ensuring continued compliance after market entry.
Company Name: HoloCare AS
AR Health Start-up
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