Medical Device & IVD Regulatory Consulting
SereniHealth delivers expert QA, RA and eQMS support to Medical Device and IVD companies navigating EU MDR, IVDR, ISO 13485 and UK MDR requirements.
Root Cause Analysis
"Most companies do not fail due to the regulations themselves — they fail due to fragmented processes, unclear ownership, and over-complex QMS systems."
We have identified three consistent failure patterns across Medical Device and IVD compliance programmes.
Disconnected procedures and siloed teams create documentation gaps that surface during Notified Body audits — gaps that could have been closed months earlier with joined-up process design.
Without a designated PRRC or a well-defined QA/RA accountability structure, compliance obligations drift — no-one is responsible, and everything becomes urgent at the worst possible time.
eQMS platforms that do not reflect real business workflows create audit inefficiencies, increase non-conformance risk, and demoralise the teams expected to maintain them.
What We Do
End-to-end regulatory strategy and technical documentation support for EU MDR and IVDR compliance, from gap analysis through to submission-ready documentation structures.
Full detailsDesign, implementation, and remediation of ISO 13485-compliant quality management systems, with focus on real-world Notified Body inspection performance.
Full detailsRegulatory compliance oversight as Person Responsible for Regulatory Compliance under EU MDR, ensuring accountability, documentation integrity, and regulatory governance.
Full detailsWe simplify and optimise quality processes before digitalisation — preventing the system complexity and audit inefficiencies that plague most eQMS implementations.
Full detailsRegulatory representation for non-UK and non-EU manufacturers, ensuring correct market access documentation, MHRA and regulatory authority alignment.
Full detailsDesign and optimisation of Corrective and Preventive Action and Post-Market Surveillance systems aligned with regulatory expectations and inspection requirements.
Full detailsWhy SereniHealth
Our team brings over 15 years of hands-on Quality Assurance and Regulatory Affairs experience spanning some of the world's leading medical device and diagnostics organisations, with direct Notified Body audit exposure across multiple product classifications.
Speak with a SereniHealth expert about your QA, RA or eQMS challenge.
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