Viraap Europe OÜ provides regulatory and quality consulting tailored to your medical device, target markets, and stage of development. We work with manufacturers and MedTech startups to align regulatory strategy, technical documentation, clinical evidence, and software lifecycle records into a consistent compliance package.
Whether you are developing a new device, addressing documentation gaps, or preparing for a notified body review or FDA submission, we translate requirements into clear priorities and practical actions for your team.
Our Services
Regulatory Strategy Planning
A tailored roadmap defining submission routes, evidence requirements, timelines, and priorities for your device and target markets.
EU MDR & FDA Pathways
Device classification, conformity assessment planning, and regulatory pathway assessment.
Technical Documentation
Preparation and remediation, including GSPR mapping and evidence traceability.
Quality Management Systems
ISO 13485 QMS implementation, maintenance, and design control support.
Clinical & Post-Market Evidence
Clinical evaluation planning and reporting (CEP/CER), PMCF, and post-market surveillance documentation.
Risk Management & Usability
ISO 14971 risk management and IEC 62366-1 usability engineering.
Software as a Medical Device
SaMD lifecycle documentation aligned with IEC 62304.
Medical Device Cybersecurity
Cybersecurity documentation aligned with IEC 81001-5-1.
Audit & Review Support
Internal audits and support in responding to notified body findings and FDA review questions.
Our Approach
We work closely with your team to develop a compliance system that reflects your device, development processes, and business priorities. Regulatory, quality, clinical, and software requirements are brought together to support consistent decisions throughout the product lifecycle.
Our goal is to create a system that serves your business in practice: guiding decisions, supporting daily operations, and providing a sound evidence base for device safety and performance.
By establishing the right foundations early, we help reduce rework and make ongoing compliance easier to maintain and more cost-effective as your product evolves.